Optilume FDA Approval

Instructions for Use
Caution: Federal law restricts this device to sale by or on the order of a physician.
Page 1 of 30 1124-004 rA Draft

Table of Contents
1 DEVICE DESCRIPTION ...................................................................................................................... 3

1.1 Optilume BPH Catheter System .................................................................................................. 3
1.2 Available Sizes and Nominal Paclitaxel Dose ............................................................................. 4
2 INDICATIONS FOR USE ..................................................................................................................... 4
3 CONTRAINDICATIONS ....................................................................................................................... 4
4 WARNINGS .......................................................................................................................................... 4
5 PRECAUTIONS ................................................................................................................................... 5
6 DRUG INFORMATION......................................................................................................................... 6
6.1 Mechanism of Action ................................................................................................................... 6
6.2 Drug Interactions ......................................................................................................................... 6
6.3 Carcinogenicity, Genotoxicity, and Reproductive Toxicology...................................................... 6
6.4 Vascular Paclitaxel Coated Device Meta-Analysis ...................................................................... 7
7 HOW SUPPLIED .................................................................................................................................. 8
8 POTENTIAL ADVERSE EFFECTS ..................................................................................................... 8
9 STORAGE ............................................................................................................................................ 8
10 RECOMMENDED ITEMS .................................................................................................................... 8
11 DIRECTIONS FOR USE ...................................................................................................................... 8
11.1 Perioperative Medications ........................................................................................................... 8
11.2 Optilume BPH Size Selection ...................................................................................................... 9
11.3 Balloon Preparation ..................................................................................................................... 9
11.4 Pre-dilation ................................................................................................................................. 10
11.5 Drug Coated Balloon Dilation .................................................................................................... 12
11.6 Post Procedure Care ................................................................................................................. 13
12 SUMMARY OF CLINICAL STUDIES ................................................................................................ 13
12.1 Primary Study ............................................................................................................................ 13
12.2 Supplemental Clinical Study ...................................................................................................... 28
13 WARRANTY ....................................................................................................................................... 29
14 SYMBOLS USED IN THE DEVICE LABELS .................................................................................... 30

1 DEVICE DESCRIPTION
1.1 Optilume BPH Catheter System
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical
therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug
coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable,
double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated
with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug
coating covers the working length of the balloon body.
Each Optilume BPH Catheter is a single inflation lumen balloon catheter that terminates in an
atraumatic tip. The folded balloon has a 14.5Fr profile. The device is inserted through the outer
sheath of a rigid cystoscope and then visualized procedurally in a side-by-side fashion with a
cystoscope. The balloon has a double lobe design with a neck separating the two sections. The
balloon neck is reinforced preventing diameter growth during the inflation process. The double
lobe design allows the balloon neck to seat in the bladder neck during inflation and helps
prevent migration of the balloon into the bladder. The distal lobe of the balloon inflates in the
bladder and aids in anchoring the device, while the proximal lobe of the balloon is positioned in
the prostatic urethra to dilate the prostate and create an anterior commissurotomy. Both the pre-
dilation and the drug coated balloon catheters are identical, the only difference being the DCB is
coated with the drug paclitaxel as shown in Figure 2.
Figure 1. Inflated Pre-dilation Balloon Catheter
Figure 2. Inflated Drug Coated Balloon Catheter
The Optilume BPH Catheter System is provided as a convenience kit, containing one pre-
dilation balloon catheter, one DCB catheter, and the accessories needed to complete a
procedure. Catalogue numbers for the different kit configurations are provided in Table 1.

Table 1. Catalogue Number Identification of the Optilume BPH Kits
Pre-dilation DCB
Catalogue Number Description
Catheter Size Catheter Size
1189-30030 Optilume BPH Prostatic Dilation Kit 30x30 90Fr x 30mm 90Fr x 30mm
1.2 Available Sizes and Nominal Paclitaxel Dose

The Optilume BPH Catheter System is available with one pre-dilation balloon size (90Fr x
30mm) and four DCB sizes which are selected based on prostatic urethral length (Table 2). The
drug coating covers the working length of the balloon component of the DCB and is evenly
distributed across the balloon surface at a nominal paclitaxel dose density of 2.4 μg/mm2. The
drug coating is released from the balloon and transferred to the prostatic urothelium during
balloon inflation.
Table 2. DCB Sizes and Nominal Paclitaxel Dose

Balloon Diameter Balloon Treatment Length (mm)
90Fr (30mm) 30 35 40 45
Paclitaxel Dose (μg)
10,262 11,433 12,567 13,661
2 INDICATIONS FOR USE

The Optilume BPH Catheter System is indicated for the treatment of obstructive urinary
symptoms associated with Benign Prostatic Hyperplasia (BPH) in PHQ 50 years of age.
3 CONTRAINDICATIONS
The Optilume BPH Catheter System is contraindicated for use in:
x Patients with known hypersensitivity to paclitaxel or structurally related compounds
x Patients with an active urinary tract infection
x Patients with an artificial urinary sphincter
x Patients with a penile prosthesis
4 WARNINGS
x The Optilume BPH Catheter System should be used only by physicians who are
experienced and knowledgeable with the clinical and technical aspects of transurethral
endoscopic treatment of BPH.
x Urotronic requires physician training on the Optilume BPH Catheter System prior to use.
Please contact Urotronic for more information.
x The Optilume BPH Catheter is supplied for single use only. Do not reprocess or re-
sterilize. Reprocessing and re-sterilizing could increase the risk of patient infection and
risk of compromised device performance.
x Each balloon catheter is supplied sterile. Do not use the catheter if the sterile barrier is
damaged or opened.
x The foil pouch and the outer surface of the inner Tyvek pouch are non-sterile. The

contents of the inner Tyvek pouch are sterile. Use proper sterile technique to transfer the
device from the inner Tyvek pouch to the sterile field.
x Do not use after the “Use By” date on the package label.
x Men should abstain from sex or use barrier contraception (wear a condom) for 30 days
post treatment to avoid exposure of sexual partner to paclitaxel. Paclitaxel may still be
present at low levels after 30 days.
x The Optilume BPH DCB contains paclitaxel, a known genotoxic aneugen capable of
causing chromosomal abnormalities in sperm. Paclitaxel is present in semen for an
extended duration after treatment with Optilume BPH. The total duration of time that
paclitaxel remains in the semen post-procedure varies, but some men have had trace
amounts detected up to 1 year after treatment. The risks associated with paclitaxel in
semen are unknown. For this reason, men with partners of child-bearing potential should
use highly effective contraceptive (to avoid fathering children) for at least 12 months
post-procedure. Urologists should engage in a discussion with prospective patients
regarding this risk and their individual family planning situation, with consideration of
longer duration contraceptive use or other precautions based on a shared decision
making process.
Paclitaxel was detectable (i.e., equal to or greater than lower limit of quantitation of 0.1
ng/mL) in semen in 4/5 (80.0%), 5/7 (71.4%), 4/10 (40.0%), and 1/3 (33.3%) of
evaluable subjects at 1 month, 3 months, 6 months, and 12 months post-treatment,
respectively.
Maximum paclitaxel concentrations in semen were 8.9, 7.5, 1.8, and 0.16 ng/mL at 1
month, 3 months, 6 months, and 12 months post-treatment, respectively, while group
mean (SD) paclitaxel concentrations in semen at those same timepoints were 2.3 (3.7),
1.3 (2.8), 0.29 (0.53), and 0.09 (0.06) ng/mL. Of the three subjects who had evaluable
data at 12 months post-treatment, one had detectable paclitaxel concentration in semen
(0.16 ng/mL).
The risks associated with these paclitaxel concentrations in semen are unknown. The
effect of treatment with the Optilume BPH DCB on sperm and spermatogenesis is also
unknown.
x Always inflate with a sterile liquid. Never inflate with air, carbon dioxide, or any other
gas.
x The balloon catheters should not be inflated in excess of the rated burst pressure (RBP).
Inflation to pressures above RBP may cause the balloon to rupture.
x During use, each balloon catheter of the Optilume BPH Catheter System should be
manipulated under direct visualization via cystoscopy.
x If resistance is encountered at any time during insertion or removal, do not force
passage. Resistance may cause damage to device or urethra. Ensure the balloon is fully
deflated and under negative pressure during withdrawal.
x Monitor for signs of anaphylaxis or hypersensitivity to paclitaxel.
5 PRECAUTIONS
x Carefully inspect the product prior to use. Do not use the catheter if it is damaged or if
the size, shape, or condition is unsuitable for the intended procedure.
x Do not immerse or wipe the Optilume BPH DCB with any fluid prior to use, as the
integrity of the drug coating may be damaged or compromised. Replace the DCB if the

balloon has come into contact with fluids prior to use.
x Use dry sterile gloves or dry gauze pads to handle the Optilume BPH DCB prior to use.
Care should be taken to minimize contact with the drug coated portion of the device.
x Never inflate the Optilume BPH DCB outside the body or prior to reaching the prostatic
urethra as it may disrupt the coating integrity.
x For proper drug delivery to the prostatic urethra, allow the drug coating on the balloon to
hydrate while in the urethra for approximately 1 minute prior to inflation. Maintain
inflation of the catheter for a minimum of 5 minutes. To optimize the anterior
commissurotomy and drug delivery, longer inflation times > 5 minutes may be performed
at the discretion of the operator.
x If the balloon catheter has a failure prior to or during inflation, replace the balloon
catheter and inflate per procedure. If failure of the Optilume BPH DCB is after inflation to
rated burst pressure (RBP), do not repeat/replace with a second DCB.
x Handle and dispose of the used device in accordance with accepted medical practice
and applicable local regulations for biohazard waste.
6 DRUG INFORMATION
6.1 Mechanism of Action
The coating of the Optilume BPH DCB contains paclitaxel, an anti-mitotic pharmaceutical agent
that specifically binds to and stabilizes microtubules. Paclitaxel has been reported to inhibit
smooth muscle cell and fibroblast proliferation and migration as well as secretion of extracellular
matrix. The combination of these effects may result in the inhibition of prostatic tissue
hyperplasia and re-fusion of the lateral lobes after achievement of the anterior commissurotomy.
6.2 Drug Interactions
Formal drug interaction studies have not been conducted for the Optilume BPH DCB. The
respective instructions for use for all drugs used in conjunction with the Optilume BPH DCB
should be consulted for interactions with paclitaxel.
Consideration should be given to the potential for systemic and local drug interactions in the
prostate in a patient who is taking a drug with known interactions to paclitaxel or when deciding
to initiate drug therapy in a patient who has been treated with the Optilume BPH Catheter
System.
The metabolism of paclitaxel is catalyzed by cytochrome P450 isoenzymes CYP2C8 and
CYP3A4, and it is a substrate of P-glycoprotein. Potential drug interactions may occur with any
drug that affects these isoenzymes. In the absence of formal drug interaction studies, caution
should be exercised when administering paclitaxel.
6.3 Carcinogenicity, Genotoxicity, and Reproductive Toxicology
The Optilume BPH DCB contains paclitaxel, a known genotoxic aneugen capable of causing
chromosomal abnormalities in sperm. Paclitaxel is present in semen for an extended duration
after treatment with Optilume BPH. The total duration of time that paclitaxel remains in the
semen post-procedure varies, but some men have trace amounts detected up to 1 year after
treatment. The risks associated with paclitaxel in semen are unknown. For this reason, men with
partners of child-bearing potential should use highly effective contraceptive (to avoid fathering
children) for at least 12 months post-procedure. Urologists should engage in a discussion with
prospective patients regarding this risk and their individual family planning situation, with
consideration of longer duration contraceptive use or other precautions based on a shared
decision making process.

Paclitaxel was detectable (i.e., equal to or greater than lower limit of quantitation of 0.1 ng/mL)
in semen in 4/5 (80%), 5/7 (71.4%), 4/10 (40.0%), and 1/3 (33.3%) evaluable subjects at 1
month, 3 months, 6 months, and 12 months post-treatment, respectively.
Maximum paclitaxel concentrations in semen were 8.9, 7.5, 1.8, and 0.16 ng/mL at 1 month, 3
months, 6 months, and 12 months post-treatment, respectively, while group mean (SD)
paclitaxel concentrations in semen at those same timepoints were 2.3 (3.7), 1.3 (2.8), 0.29
(0.53), and 0.09 (0.06) ng/mL. Of the three subjects who had evaluable data at 12 months post-
treatment, one had detectable paclitaxel concentration in semen (0.16 ng/mL).
The risks associated with these paclitaxel concentrations in semen are unknown. The effect of
treatment with the Optilume BPH DCB on sperm and spermatogenesis is also unknown.
6.4 Vascular Paclitaxel Coated Device Meta-Analysis
A meta-analysis of randomized, controlled trials for the use of paclitaxel coated devices in
treating patients with peripheral arterial disease (PAD) was published by Katsanos et. al in
2018. 1 This analysis suggested the possibility of an increased risk of mortality resulting from the
use of paclitaxel-coated vascular devices. This higher risk of death was observed at time points
at least two years after treatment with the paclitaxel-containing devices. The presence and
magnitude of the late mortality risk should be interpreted with caution because of multiple
limitations in the available data, including wide confidence intervals due to a small sample size,
pooling of studies of different paclitaxel-coated devices that were not intended to be combined,
substantial amounts of missing study data, no clear evidence of a paclitaxel dose effect on
mortality, and no identified pathophysiologic mechanism for the late deaths.
In January 2021, Nordanstig and colleagues published interim results of a large, randomized
national registry trial evaluating paclitaxel coated devices against uncoated control devices that
showed no significant increase in mortality for paclitaxel coated devices through a median of 2.5
years follow-up. 2 These results complement published outcomes from large national health
insurance databases in the US and Germany showing no increase in mortality risk with the use
of paclitaxel-coated devices. Longer term follow-up through 5 years is ongoing for these studies.
Patients receiving the Optilume BPH Catheter System will be treated with a paclitaxel-coated
balloon for a different condition (BPH) in a different part of the body (the prostate). Unlike the
cardiovascular application, the drug is deposited on the urethra and not in the blood, although a
small amount of drug can diffuse through the urethra into the blood. The mortality rate in the
PINNACLE study evaluating the Optilume BPH Catheter System was 0.6 deaths per 100 patient
follow-up years, which is no different than the expected rate of mortality for men in this age
group.
1
Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated
balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized
controlled trials. J Am Heart Assoc. 2018;7(24):e011245.
2
Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, et al. Mortality with paclitaxel-coated
devices in peripheral artery disease. N Engl J Med. 2020;383(26):2538-46.

7 HOW SUPPLIED
The Optilume BPH Catheter System is supplied as a convenience kit containing:
x One (1) Optilume BPH Prostatic Pre-dilation Catheter
x One (1) Optilume BPH Prostatic Dilation Drug Coated Balloon Catheter
x One (1) 60mL Inflation device with pressure gauge and 3-way stopcock
x One (1) 3-way stopcock
x Two (2) Tuohy-Borst adapters
Each component in the Optilume BPH kit is supplied sterile and intended for single use only.
Each Optilume BPH Catheter is sterilized by ethylene oxide. Each balloon catheter is in a
double pouch packaging system (foil and Tyvek pouches) contained within a single unit box.
8 POTENTIAL ADVERSE EFFECTS
Potential adverse effects after treatment with the Optilume BPH Catheter System are similar to
standard cystoscopic procedures and mechanical dilation and include, but are not limited to
fever, bleeding, pain, urinary tract infection, false route of the urethra, dysuria, difficult urination,
frequency/urgency/irritative urinary symptoms, urinary retention and related symptoms, blood in
urine (hematuria), urinary incontinence, urethrorrhagia, blood in semen (hematospermia),
ejaculatory dysfunction, bladder perforation, urethral and/or bladder neck strictures, injury or
perforation to the urethra, sphincter or prostatic capsule, and inflammation of genitourinary
system (prostatitis, orchitis, balanitis).
Although systemic effects from the paclitaxel coating are not anticipated, adverse effects
observed during intravenous administration of paclitaxel for chemotherapy include, but are not
limited to, allergic reaction, alopecia, anemia, gastrointestinal symptoms, hematological
dyscrasia (including leucopenia, neutropenia, thrombocytopenia), hepatic enzyme changes,
myalgia/arthralgia, myelosuppression, and peripheral neuropathy. Maximum systemic paclitaxel
levels after treatment with the Optilume BPH DCB are more than 100 times lower than with IV
administration of paclitaxel for chemotherapy.
9 STORAGE
The Optilume BPH Catheter System should be stored at room temperature between 15°C and
30°C (59°F and 86°F) in a dry location in its original packaging. The device should be used prior
to the “Use By” date on the package label.
10 RECOMMENDED ITEMS
Prepare the following items using sterile technique:
x Lubricious surgical gel to aid with device insertion
x 60 mL inflation device with pressure gauge
x Three-way stopcock
x Tuohy-Borst adapter
x Rigid cystoscope (minimum sheath size 19.5F)
x Sterile saline
11 DIRECTIONS FOR USE
11.1 Perioperative Medications
It is recommended that physicians follow guidelines for pre-procedure medications and
preparation for a cystoscopic urethral procedure, including the administration of a pre-procedure

antibiotic as appropriate. If a urinary tract infection (UTI) is present at the time of treatment, the
patient must be treated until the infection is cleared before the Optilume BPH procedure can
take place.
The prostate is a highly vascularized organ and the Optilume BPH procedure, like other
transurethral procedures for the treatment of BPH, may cause bleeding within the prostatic
urethra. Peri-operative management of anticoagulant and antiplatelet medications is at the
discretion of the treating physician and should balance the patient risk of thromboembolic
events against the risk of hemorrhagic events.
11.2 Optilume BPH Size Selection
Selection of the appropriate kit for the Optilume BPH procedure is based on the measured
prostatic urethral length (PUL) of the patient. Use of transrectal ultrasound (TRUS) to determine
the PUL is recommended. The PUL measurement should be taken in the mid-sagittal plane as a
direct line from the base of the bladder neck to the proximal edge of the external urethral
sphincter.
Note: If an intravesical prostatic protrusion (IPP) is present, the measurement should be from
the base of the bladder neck, NOT the tip of the IPP.
Figure 3. Mid-sagittal TRUS Image Showing PUL Measurement
Table 3: Optilume BPH DCB Size Selection

PUL Measurement PUL 32-37mm PUL 37-42mm PUL 42-47mm PUL >47mm
Catalogue Number 1189-30030 1189-30035 1189-30040 1189-30045
(DCB Size) (90Fr x 30mm) (90Fr x 35mm) (90Fr x 40mm) (90Fr x 45mm)
11.3 Balloon Preparation

Before use, each balloon catheter in the Optilume BPH kit must be prepared for use by
evacuating air from the balloon catheter. The balloon lumen of the catheter contains air and the
air must be displaced to make certain that only liquid fills the balloon while the catheter is in the
urethra. Do not remove the balloon protector sheath during catheter preparation.
1. Open the inflation device package, remove the 3-way stopcock, and attach it to the
Tuohy-Borst adapter.
2. Connect the Tuohy-Borst valve to the proximal catheter shaft. Ensure that the catheter

shaft does not interfere with the 3-way stopcock operation.
3. Fill the inflation device half-way with sterile saline and attach it to the stopcock. Turn the
stopcock so fluid can flow between the inflation device and the balloon catheter.
4. With the inflation device pointing downwards, draw back plunger to full volume of syringe
(this creates maximum negative pressure and allows air to evacuate above the fluid
level) and hold until no air bubbles can be seen coming out of the saline in the syringe.
Repeat as needed to purge the air from the catheter.
5. With catheter preparation complete, disconnect the Tuohy-Borst valve from the catheter
shaft.
6. Fill the inflation device with 50cc normal saline and purge air from the line.
11.4 Pre-dilation
Pre-dilation of the prostatic urethra should be completed with the Optilume BPH Pre-dilation
Catheter to initiate an anterior commissurotomy prior to treatment with the Optilume BPH DCB
Catheter.
1. Prepare the Optilume BPH Pre-dilation Catheter for use per Section 11.3.
2. Assemble and advance the rigid cystoscope (minimum sheath size 19.5Fr) through the
urethra and into the bladder. Remove the optics and bridge (if applicable) leaving an
open pathway through the rigid sheath into the bladder.
3. Remove the balloon protector sheath from the Optilume BPH Pre-dilation Balloon.
4. Insert the balloon catheter through the rigid cystoscope sheath and into the bladder.
5. Slide the outer rigid cystoscope sheath out of the patient and over the balloon catheter
shaft while maintaining the balloon catheter in position.
6. Reassemble the rigid cystoscope sheath with the bridge and optics.
Note: A smaller cystoscope sheath (e.g., 18F) may be used to visualize the balloon
during placement.
7. Attach the Tuohy-Borst adapter with inflation device to the proximal catheter shaft.
8. Insert the reassembled cystoscope transurethrally up to the external sphincter. The
Optilume BPH Catheter is used side-by-side with a cystoscope.
9. Locate the external sphincter with the cystoscope and position the tip of the cystoscope
so visualization of the external sphincter can be maintained throughout the procedure.
10. Adjust the position of the balloon by pushing/pulling the catheter shaft until the blue

positioning marker is visible at the distal edge of the external urethral sphincter (Figure
4).
Figure 4. Positioning of the Balloon Within the Prostatic Urethra
11. With the balloon properly positioned, inflate slowly while maintaining traction to seat the
balloon at the bladder neck and prevent proximal migration into the bladder. During
inflation, monitor the location of the blue positioning marker with the cystoscope. If the
marker migrates proximally into the external sphincter (e.g., is no longer visible) or the
treatment balloon has slipped into the bladder, deflate, and reposition the balloon as
above and repeat the dilation process.
Warning: If migration of the balloon distally into the external sphincter (toward the user)
is observed during inflation, immediately stop, and reposition.
12. Continue slow inflation until the anterior prostatic commissure is separated. Achievement
of an anterior commissurotomy is typically accompanied by a sudden drop in pressure
on the inflation device pressure gauge as resistance from the tissue is overcome.
Note: Once the balloon is inflated, check for migration into the bladder by pressing the
catheter shaft gently towards the bladder. If the catheter shaft moves freely, the balloon
has likely migrated into the bladder. If migration is observed, deflate the balloon,
reposition the catheter as above, and repeat the dilation process. Do not repeat this
procedure more than 3 times.
Warning: The balloon catheters should not be inflated to pressures above the rated
burst pressure (RBP). Inflation in excess of RBP may cause the balloon to rupture.
13. After complete dilation, deflate the balloon and visually confirm the anterior
commissurotomy by advancing the cystoscope into the prostatic urethra.
Note: If difficulty is encountered visualizing commissurotomy, increase fluid
flow/pressure to improve visibility.
14. Do not exceed 3 inflation cycles to rated burst pressure. If a commissurotomy is not
achieved after 3 inflation cycles, deflate, and withdraw the Optilume BPH Pre-dilation
Balloon per the steps below and proceed to dilation with the DCB.
15. After initiation of the commissurotomy is confirmed, remove the cystoscope.
16. Deflate the balloon by applying negative pressure with the inflation device to aspirate

liquid from the balloon. Once the inflation device is filled with fluid, detach from the
stopcock, purge fluid into a reservoir, reattach to the catheter, and repeat the aspiration
process to ensure complete aspiration of liquid from balloon.
Warning: If resistance is encountered at any time during insertion or removal, do not
force passage. Resistance may cause damage to the device or urethra. Ensure the
balloon is fully deflated and under negative pressure during withdrawal.
17. When the balloon is completely deflated, maintain vacuum and gently pull on the
catheter shaft to withdraw the catheter from the patient’s body.
11.5 Drug Coated Balloon Dilation
1. Prepare the Optilume BPH DCB for use per Section 11.3.
2. Advance the rigid cystoscope through the urethra and into the bladder. Remove the
optics and bridge (if applicable) leaving an open pathway through the rigid sheath into
the bladder.
3. Remove the balloon protector sheath from the Optilume BPH DCB.
4. Insert the Optilume BPH DCB through the rigid cystoscope and into the bladder.
5. Slide the outer rigid cystoscope sheath out of the patient and over the balloon catheter
shaft while maintaining the balloon catheter in position.
6. Reassemble the rigid cystoscope sheath with the bridge and optics.
7. Attach the Tuohy-Borst adapter with inflation device to the proximal catheter shaft of the
Optilume BPH DCB.
8. Insert the reassembled cystoscope transurethrally up to the external sphincter. The
Optilume BPH Catheter is used side-by-side with a rigid cystoscope.
9. Locate the external sphincter with the cystoscope and position the tip of the cystoscope
so visualization of the external sphincter can be maintained through the procedure.
10. Adjust the position of the balloon by pushing/pulling the catheter shaft until the blue
positioning marker is visible at the distal edge of the external urethral sphincter (Figure
4). This step should be completed in approximately 1 minute while the drug coating is
hydrating, such that the balloon can be inflated after hydration is complete.
11. With the balloon properly positioned, inflate slowly while maintaining traction to seat the
balloon at the bladder neck and prevent proximal migration into the bladder. During
inflation, monitor the location of the blue positioning marker with the cystoscope. If the
marker migrates proximally into the external urethral sphincter (e.g., is no longer visible)
or the treatment balloon has slipped into the bladder, deflate and reposition the balloon
as above and repeat the dilation process.
Warning: If migration of the balloon distally into the external sphincter (toward the user)
is observed during inflation, immediately stop and reposition.
12. With the balloon properly positioned, inflate the balloon using the inflation device.
Maintain inflation for a minimum of 5 minutes to assure complete propagation of the
anterior commissurotomy and appropriate drug delivery. To optimize the anterior
commissurotomy and drug delivery, inflation times > 5 minutes may be utilized at the
discretion of the operator.
Warning: The balloon catheters should not be inflated to pressures above the rated
burst pressure (RBP). Inflation in excess of RBP may cause the balloon to rupture.

13. Once the balloon is inflated, check for migration into the bladder by pressing the catheter
shaft gently towards the bladder. If the catheter shaft moves freely, the balloon has likely
migrated into the bladder. If migration is observed, deflate the balloon, reposition the
catheter as above, and repeat the dilation process.
14. After completion of the commissurotomy, remove the cystoscope.
Note: Avoid visualizing the prostatic urethra with the cystoscope after dilation with the
Optilume BPH DCB, as the irrigation fluid from the scope may disturb the drug coating
delivered to the prostatic urethra.
15. Deflate the balloon by applying negative pressure with the inflation device to aspirate
liquid from the balloon. Once the inflation device is filled with fluid, detach from the
stopcock, purge fluid into a reservoir, reattach to the catheter, and repeat the aspiration
process to ensure complete aspiration of liquid from the balloon.
Warning: If resistance is encountered at any time during insertion or removal, do not
force passage. Resistance may cause damage to device or urethra. Ensure the balloon
is fully deflated and under negative pressure during withdrawal.
16. When the balloon is completely deflated, maintain vacuum and gently pull on the
catheter shaft to withdraw the catheter from the patient’s body.
11.6 Post Procedure Care
1. Upon completion of the dilation procedure, insert a Foley catheter and flush the bladder
with sterile saline until the effluent returns clear.
Note: If difficulty is encountered during placement of the Foley catheter, it is
recommended to place a guidewire and advance a council tip Foley over the guidewire
to aid in placement. Rigid catheter guides are not recommended.
2. It is recommended to place the Foley catheter on mild-to-moderate traction during the
recovery period post-procedure to provide tamponade of any bleeding prostatic vessels.
Note: Use of traction for approximately 30 minutes post-procedure with at least a 30cc
Foley balloon was found to reduce the rate of hematuria complications during clinical
trials.
3. The Foley catheter should remain in place for a minimum of 2 days to allow adequate
healing and absorption of the drug into the prostatic adenoma.
12 SUMMARY OF CLINICAL STUDIES

12.1 Primary Study
The PINNACLE study was a prospective, multicenter, double blind, 2:1 randomized controlled
trial comparing the Optilume BPH Catheter System to a sham control procedure. In addition, a
single arm of 15 non-randomized subjects were enrolled and treated with the Optilume BPH
Catheter System to gather paclitaxel pharmacokinetic data. Subjects randomized to the Sham
arm were allowed to cross over to receive the Optilume BPH Catheter System prior to the close
of their 12-month visit window.
Study enrollment began in January 2020 and was completed in September 2021. A total of 148
subjects were randomized in the study, 100 to the Optilume BPH arm and 48 to the Sham arm
at 18 investigational sites. Treatment with the Optilume BPH Catheter System included use of
the Optilume BPH Pre-dilation Balloon to initiate an anterior commissurotomy followed by
dilation with the Optilume BPH DCB to further dilate and deliver drug to the prostatic urethra.

The sham procedure utilized rigid cystoscopy followed by insertion of a sheathed (21F)
Optilume BPH Pre-dilation Balloon that was modified to prevent inflation. Follow-up was
completed at Foley removal, 14 days, 30 days, 3 months, 6 months, and 12 months and will be
performed annually through 5 years for subjects treated with the Optilume BPH Catheter
System.
12.1.1 Subject Accountability
At the time of database lock, of 477 patients enrolled in the PMA clinical study, 148 were
randomized, and 14 included in the PK sub-study. Subject disposition and visit compliance for
the randomized cohort through 12 months is summarized in Table 4 and Figure 5.
Withdrawals prior to the 12-month visit included 10 subjects randomized to the Optilume BPH
arm (2 withdrew prior to receiving the study treatment, 2 lost to follow-up, 2 withdrew consent, 2
underwent a BPH surgical procedure, 2 initiated BPH medications) and 2 subjects randomized
to the Sham arm (2 initiated BPH medications). Twenty subjects in the Sham arm crossed over
to receive Optilume BPH prior to the 12-month visit.
Primary efficacy and secondary endpoint analyses were performed using the intent-to-treat
(ITT) data set which included all randomized subjects. Safety analyses were performed using
the as-treated (AT) data set based on the treatment received. The AT data set excludes two
subjects who were randomized to the Optilume BPH arm but did not receive the study
treatment.
Table 4. Visit Compliance for Randomized Cohort

Visit Compliance1
Study Visit Optilume BPH Sham
(n=100) (n=48)
Participants who received study treatment 98.0% (98/100) 100.0% (48/48)
Participants who completed Foley Removal 100.0% (98/98) 100.0% (48/48)
Participants who completed 14 Day visit 98.0% (96/98) 97.9% (47/48)
Participants who completed 30 Day visit 99.0% (97/98) 100.0% (48/48)
Participants who completed 3 Month visit 97.9% (94/96) 100.0% (48/48)
1Denominator represents the number of subjects eligible for a visit, while the numerator represents the number of
visits completed. Subjects that are withdrawn from the study prior to the visit window opening are excluded from the
denominator.

¥
For the primary endpoint intent-to-treat (ITT) analysis, subjects receiving alternative BPH
therapy were imputed as having no improvement, while endpoint status for subjects with missing
data were imputed via multiple imputation.
Figure 5. Subject Accountability Diagram for Randomized Cohort
12.1.2 Study Population Demographics and Baseline Parameters

The demographics of the study population are typical for a BPH study performed in the US.
Demographics, baseline genitourinary medical history, and baseline prostate characteristics
were well matched between groups.
Table 5. Demographics and Genitourinary Medical History

Optilume BPH Sham
Characteristic (N=100) (N=48) P-Value1
Demographics
Age 64.5 ± 6.4 (98) 65.5 ± 5.6 (47) 0.3769

Optilume BPH Sham
Characteristic (N=100) (N=48) P-Value1
Race
American Indian or Alaska Native 0.0% (0/100) 0.0% (0/48) 0.1877
Asian 2.0% (2/100) 0.0% (0/48)
Black or African American 3.0% (3/100) 10.4% (5/48)
Hawaiian or Pacific Islander 0.0% (0/100) 0.0% (0/48)
White 94.0% (94/100) 89.6% (43/48)
Multi-Racial 1.0% (1/100) 0.0% (0/48)
Ethnicity
Hispanic or Latino 13.0% (13/100) 6.3% (3/48) 0.2157
Not Hispanic or Latino 87.0% (87/100) 93.8% (45/48)
BMI 29.32 ± 4.45 (100) 29.06 ± 4.72 (48) 0.7420
Medical History
Urinary Incontinence
No 100.0% (100/100) 100.0% (48/48) N/A
Yes 0.0% (0/100) 0.0% (0/48)
LUTS
Dysuria 16.0% (16/100) 16.7% (8/48) 0.9180
Frequency 91.0% (91/100) 100.0% (48/48) 0.0586
Hesitancy 73.0% (73/100) 79.2% (38/48) 0.4173
Incomplete Voiding 85.0% (85/100) 91.7% (44/48) 0.2564
Nocturia 91.0% (91/100) 95.8% (46/48) 0.3445
Poor Stream 89.0% (89/100) 91.7% (44/48) 0.7745
Terminal Dribbling 49.0% (49/100) 52.1% (25/48) 0.7254
Urgency 80.0% (80/100) 91.7% (44/48) 0.0715
Hematuria 6.0% (6/100) 2.1% (1/48) 0.4284
Retention 13.0% (13/100) 18.8% (9/48) 0.3573
Other Genitourinary History
Kidney Stone 13.0% (13/100) 20.8% (10/48) 0.2182
Erectile Dysfunction 56.0% (56/100) 54.2% (26/48) 0.8336
Bladder Stone 3.0% (3/100) 0.0% (0/48) 0.5512
Urinary Tract Infection 6.0% (6/100) 4.2% (2/48) 0.7235
Bacterial Prostatitis 5.0% (5/100) 4.2% (2/48) 1.0000
Cystitis 2.0% (2/100) 0.0% (0/48) 0.5587
Other 34.0% (34/100) 29.2% (14/48) 0.5565
Prostate Specific Antigen (ng/mL) 2.42 ± 1.98 (100) 2.20 ± 1.82 (48) 0.5135
IPSS Score 23.4 ± 5.5 (100) 24.3 ± 5.8 (48) 0.3916
Qmax (mL/sec) 8.85 ± 2.17 (100) 8.95 ± 1.80 (48) 0.7888
Post-Void Residual Volume (mL) 84.1 ± 70.2 (99) 89.4 ± 73.9 (48) 0.6750
1Continuousvariables tested with two-sample t-test and categorical variables tested with chi square test.
When expected cell counts were < 5, then an Exact Chi-Square test was used.

Table 6. Baseline Prostate Characteristics
Optilume BPH Sham
Prostate Characteristics (N=100) (N=48) P-Value1
Prostate Width (mm) 48.90 ± 6.72 (100) 49.99 ± 5.05 (48) 0.2754
Prostate Height (mm) 37.07 ± 7.52 (100) 36.18 ± 7.14 (48) 0.4976
Prostate Length (mm) 46.62 ± 6.33 (100) 46.46 ± 5.39 (48) 0.8791
Prostate Volume (mL) 44.88 ± 14.53 (100) 45.00 ± 13.16 (48) 0.9633
Intravesical Prostatic Protrusion 28.0% (28/100) 33.3% (16/48) 0.5064
IPP Size (mm) 5.07 ± 2.19 (28) 5.31 ± 1.54 (15) 0.7059
1Continuous variables tested with two-sample t-test and categorical variables tested with chi-square test.
12.1.3 Efficacy Outcomes

12.1.3.1 Primary Efficacy Endpoint
The primary efficacy endpoint was a comparison of the change in International Prostate
Symptom Score (IPSS) at 3 months for the Control group and at 12 months for the Optilume
BPH group. The endpoint incorporated a super-superiority margin of 25% for the sham effect at
3 months. The analysis was based on the ITT cohort which included 148 evaluable subjects (48
sham subjects at 3 months and 100 Optilume BPH subjects at 12 months). Subjects undergoing
alternative therapy for ongoing/recurrent LUTS prior to the scheduled timepoint were imputed as
having no change from baseline. Missing data were accounted for using multiple imputation.
Incorporating the 25% super superiority margin, the imputed difference between arms was +1.4
(p=0.178). The improvement in IPSS for the Optilume BPH arm at 12 months did not reach
statistical significance with a 25% super-superiority margin when compared to the improvement
in the Sham arm at 3 months (Table 7).
Table 7. Primary Efficacy Endpoint – Improvement in IPSS (ITT, Multiple Imputation)

Sham Optilume BPH
Difference
(3 Months, (12 Months,
[95%CI]
Variable N=48) N=100)
Improvement in IPSS 8.0 3.4
Mean [95%CI] [5.8, 10.3] 11.5 [0.6, 6.2]
Improvement in IPSS (w/ 25% Margin) 10.0 [9.7, 13.2] 1.4
Mean [95%CI] [7.5, 12.5] [-1.6, 4.5]
P-value is based on a two-sample, independent t-test.
A post-hoc analysis was performed comparing the improvement in IPSS at 12 months for the
Optilume BPH group to the improvement of a historical sham control at 3 months based on a
systematic review of the literature of sham endoscopic procedures in randomized trials for BPH.
A total of 8 studies were included in the analysis and used to generate the pooled sham effect
(weighted average) across studies. 3-10 Four studies reported a paired change in IPSS from
baseline to 3 months. 5,6,8,9 Comparing the improvement in IPSS against the pooled sham effect
from the literature as a performance goal shows a benefit for Optilume BPH both with and
without a 25% super-superiority margin (Table 8). A similar outcome is seen when utilizing only
3
Albala DM, Fulmer BR, Turk TM, Koleski F, Andriole G, Davis BE, et al. J Endourol. 2002;16(1):57-61.
4
Barbalias GA, Liatsikos EN. Int J Urol. 1998;5(2):157-62.
5
Blute ML, Patterson DE, Segura JW, Tomera KM, Hellerstein DK. J Endourol. 1996;10(6):565-73.
6
Chughtai B, Elterman D, Shore N, Gittleman M, Motola J, Pike S, et al. Urology. 2021;153:270-6.
7
Larson TR, Blute ML, Bruskewitz RC, Mayer RD, Ugarte RR, Utz WJ. Urology. 1998;51(5):731-42.
8
McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, et al. J Urol. 2016;195(5):1529-38.
9
Roehrborn CG, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, et al. J Urol. 2013;190(6):2161-7.
10
Roehrborn CG, Preminger G, Newhall P, Denstedt J, Razvi H, Chin LJ, et al. Urology. 1998;51(1):19-28.

those publications reporting paired change scores.
Table 8. Comparison of Literature Sham Improvement in IPSS at 3 Months to Optilume

BPH at 12 Months
Literature Sham Optilume BPH
Variable (3 Months) (12 Months)
Composite Literature Outcomes 5.9
(n=401)
Composite Literature Outcomes 7.4
(w/ 25% Super Superiority Margin) (n=401) 11.5 ± 7.8
Composite Literature Outcomes (paired) 5.6 ± 8.0 (n=94)
(n=215)
Composite Literature Outcomes 7.0 ± 10.0
(paired, w/ 25% Super Superiority Margin) (n=215)
Optilume BPH mean improvement utilizing ‘Retreatments Imputed’ methodology, where those receiving
alternative treatment are imputed as having no improvement.
12.1.3.2 Secondary Endpoints

Hypotheses for the secondary endpoints were not formally tested because the study failed to
meet its primary effectiveness endpoint and supplemented by post-hoc analysis.
Secondary Endpoint 1 – Average IPSS Improvement in Test Arm at 12 Months
The average percent improvement in IPSS from baseline to 12 months was compared against a
performance goal of 30%. Subjects undergoing alternative therapy for ongoing/recurrent LUTS
prior to the scheduled timepoint were considered as having no improvement, while subjects
considered missing at random were imputed utilizing multiple imputation as per the primary
efficacy endpoint analysis. The average improvement from baseline to 12 months for the
Optilume BPH arm was 49%, which is greater than the target 30% threshold.
Table 9. Secondary Endpoint 1 – Average IPSS Improvement at 12 Months

Optilume BPH
Endpoint (n=100)
% Improvement in IPSS
Mean ± SE 49.1% ± 3.2%
[95% CI] [42.7%, 55.4%]
Secondary Endpoint 2 – Responder Rate at 3 Months (Optilume BPH) vs 3 Months
(Sham)
The rate of responders at 3 months in the Optilume BPH arm was compared to the rate of
responders at 3 months in the Sham arm. A responder is defined as a subject who has an IPSS
LPSURYHPHQWRIDWWKHOLVWHGWLPHSRLQWFRPSDUHGWREDVHOLQH6XEMHFWVXQGHUJRLQJ
alternative therapy for ongoing/recurrent LUTS prior to the scheduled timepoint were considered
as having no improvement in the analysis. The responder rate at 3 months was numerically
higher in the Optilume BPH arm compared to the Sham arm.
Table 10. Secondary Endpoint 2 – Responder Rate at 3 Months

Endpoint Sham Optilume BPH
Responder Rate (30%)
Proportion (n/N) 52.1% (25/48) 68.8% (66/96)
[95% CI] [37.2%, 66.7%] [58.5%, 77.8%]
N=4 patients excluded from analysis due to missing values.

Secondary Endpoint 3 – Responder Rate at 12 Months (Optilume BPH) vs 3 Months
(Sham)
The rate of responders at 12 months in the Optilume BPH arm was compared to the rate of
responders at 3 months in the Sham arm. A responder is defined as a subject who has an IPSS
LPSURYHPHQWRIDWWKHOLVWHGWLPHSRLQWFRPSDUHGWREDVHOLQH6XEMHFWVXQGHUJRLQJ
alternative therapy for ongoing/recurrent LUTS prior to the scheduled timepoint were considered
as having no improvement in the analysis. The responder rate at 12 months in the Optilume
BPH arm was higher than the responder rate at 3 months in the Sham arm (76.6% vs 52.1%).
Table 11. Secondary Endpoint 3 – Responder Rate at 12 Months

Sham Optilume BPH
Endpoint (3 months) (12 months)
Responder Rate (30%)
Proportion (n/N) 52.1% (25/48) 76.6% (72/94)
[95% CI] [37.2%, 66.7%] [66.7%, 84.7%]
N=6 patients excluded from analysis due to missing values.
Secondary Endpoint 4 – Change in Qmax

The change in Qmax at 12 months in the Optilume BPH arm was compared to the change in
Qmax at 3 months in the Sham arm. Subjects opting to receive alternative therapy or
withdrawing due to perceived lack of effectiveness were considered as having no improvement.
The Optilume BPH arm showed a higher increase in Qmax at 12 months when compared to the
increase in Qmax seen in the Sham arm at 3 months.
Table 12. Secondary Endpoint 4 Change in Qmax from Baseline

Optilume BPH – Sham –
Point Estimate of
Variable 12 Months 3 Months
Difference [95%CI]
(n=87) (n=43)
Change in Qmax +9.7 ± 10.14 +5.5 ± 7.44 -4.2
(Mean ± SD, [95% CI]) [7.5, 11.8] [3.2, 7.8] [-7.6, -0.8]
Uroflows with a voided volume <150mL were excluded from this analysis.
12.1.3.3 Ancillary Endpoints

Analysis of the following ancillary endpoints demonstrated improvement through 12 months
follow-up.
Ancillary Endpoint 1 – Additional Responder Analyses with a Responder Defined as IPSS
Improvement of 35%, 40% and 50%
The change in IPSS for both arms is presented using a Retreatments Imputed analysis which
carries forward baseline values for subjects considered treatment failures (Table 9). The
proportion of subjects with at least 35%, 40% and 50% improvement in IPSS is higher in the
Optilume BPH arm compared to the Sham arm at all timepoints evaluated (Table 10).

Table 9. Change in IPSS Over Time (Retreatments Imputed)
Group Baseline 14 Day 30 Day 3 Month 6 Month 12 Month
Optilume BPH
(N=100)
n 100 87 97 96 94 94
Mean ± SD 23.4 ± 5.5 15.7 ± 8.9 13.4 ± 7.0 13.0 ± 7.6 12.8 ± 7.8 11.8 ± 7.6
Median 23.0 14.0 13.0 12.0 12.5 10.0
Min, Max 13, 34 1, 35 1, 35 0, 32 1, 33 0, 32
Sham (N=48)
n 48 47 48 48 47 48
Mean ± SD 24.3 ± 5.8 15.1 ± 7.6 15.0 ± 8.0 16.2 ± 8.9 18.1 ± 7.8 19.5 ± 9.2
Median 25.5 13.0 13.0 15.0 18.0 21.0
Min, Max 12, 34 3, 33 2, 33 4, 34 5, 32 4, 34
Table 10. Responder Rate Based on IPSS Improvement of 35%, 40% and 50%
Improvement of percentage in IPSS (%)

Visit
Optilume Optilume Optilume
BPH Sham BPH Sham BPH Sham
30 Day
% (n/N) 63.9% (62/97) 54.2% (26/48) 59.8% (58/97) 52.1% (25/48) 43.3% (42/97) 37.5% (18/48)
95% CI1 53.5%, 73.4% 39.2%, 68.6% 49.3%, 69.6% 37.2%, 66.7% 33.3%, 53.7% 24.0%, 52.6%
3 Month
% (n/N) 66.7% (64/96) 50.0% (24/48) 61.5% (59/96) 45.8% (22/48) 47.9% (46/96) 39.6% (19/48)
95% CI1 56.3%, 76.0% 35.2%, 64.8% 51.0%, 71.2% 31.4%, 60.8% 37.6%, 58.4% 25.8%, 54.7%
6 Month
% (n/N) 68.1% (64/94) 36.2% (17/47) 60.6% (57/94) 31.9% (15/47) 45.7% (43/94) 25.5% (12/47)
95% CI1 57.7%, 77.3% 22.7%, 51.5% 50.0%, 70.6% 19.1%, 47.1% 35.4%, 56.3% 13.9%, 40.3%
12 Month
% (n/N) 71.3% (67/94) 31.3% (15/48) 69.1% (65/94) 27.1% (13/48) 59.6% (56/94) 22.9% (11/48)
95% CI1 61.0%, 80.1% 18.7%, 46.3% 58.8%, 78.3% 15.3%, 41.8% 49.0%, 69.6% 12.0%, 37.3%
Note: Timepoints after study exit due to treatment failure or crossover to treatment are imputed as failures
1Confidence intervals (CI) are estimated using the Clopper-Pearson (exact) approach.
Ancillary Endpoints 2 and 8 – Change in Post-void Residual (PVR) Urine Volume and
Peak Flow Rate (Qmax)
Table 11. Change in Qmax and PVR Over Time (Retreatments Imputed)
Measure Group Baseline 30 Day 3 Month 6 Month 12 Month
QMax Optilume BPH
(mL/sec) (N=100)
n 98 79 81 86 87
Mean ± SD 8.9 ± 2.2 17.6 ± 9.0 18.6 ± 9.7 16.9 ± 8.9 18.5 ± 10.2
Median 8.9 16.8 17.2 14.7 17.0
Min, Max 5, 12 4, 49 4, 66 5, 59 5, 60
Sham (N=48)
n 48 43 43 43 48
Mean ± SD 8.9 ± 1.8 13.2 ± 6.3 14.5 ± 7.8 13.2 ± 6.8 12.1 ± 6.5
Median 9.0 11.5 13.0 10.9 10.0
Min, Max 6, 12 5, 32 5, 42 6, 38 6, 38

Measure Group Baseline 30 Day 3 Month 6 Month 12 Month
PVR (mL) Optilume BPH
(N=100)
n 99 92 91 90 90
Mean ± SD 84.1 ± 70.2 60.5 ± 54.4 69.5 ± 68.6 61.4 ± 58.8 59.5 ± 52.6
Median 69.0 47.5 55.0 45.0 42.5
Min, Max 0, 298 0, 248 0, 435 0, 313 0, 202
Sham (N=48)
n 48 46 48 47 47
Mean ± SD 89.4 ± 73.9 91.8 ± 81.6 98.4 ± 102.4 96.9 ± 103.8 93.4 ± 98.0
Median 66.0 76.5 57.0 56.0 69.0
Min, Max 0, 284 0, 348 0, 385 10, 534 0, 500
Voided volumes < 150 mL are excluded from the Qmax analysis.
Ancillary Endpoint 3 – Change in Sexual Function (International Index of Erectile

Function (IIEF), Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD))
Table 12. IIEF Over Time (As Observed)

Measure Group Baseline 3 Month 6 Month 12 Month
Erectile Optilume BPH (N=98)
Function n 97 92 91 87
Mean ± SD 15.6 ± 10.3 16.5 ± 10.8 17.3 ± 11.0 17.1 ± 11.1
Median 15.0 16.5 19.0 16.0
Min, Max 1, 30 1, 30 1, 30 1, 30
Sham (N=48)
n 48 47 35 26
Mean ± SD 16.8 ± 9.3 17.6 ± 9.8 19.8 ± 8.7 20.1 ± 8.4
Median 19.0 18.0 22.0 22.5
Min, Max 1, 30 1, 30 1, 30 4, 30
Intercourse Optilume BPH (N=98)
Satisfaction n 98 92 91 88
Mean ± SD 5.7 ± 5.0 5.8 ± 5.2 6.5 ± 5.4 6.4 ± 5.4
Median 7.0 7.0 8.0 8.0
Min, Max 0, 15 0, 14 0, 15 0, 15
Sham (N=48)
n 48 47 35 26
Mean ± SD 6.3 ± 4.9 6.9 ± 5.0 7.5 ± 4.5 8.3 ± 4.4
Median 8.0 7.0 9.0 9.5
Min, Max 0, 15 0, 15 0, 13 0, 14
Orgasmic Optilume BPH (N=98)
Function n 98 92 91 88
Mean ± SD 5.8 ± 3.8 5.6 ± 3.9 6.7 ± 3.9 6.3 ± 3.8
Median 6.5 6.0 8.0 8.0
Min, Max 0, 10 0, 10 0, 10 0, 10
Sham (N=48)
n 48 47 35 26
Mean ± SD 6.1 ± 3.5 6.3 ± 3.5 6.6 ± 2.9 7.3 ± 2.9
Median 6.5 7.0 6.0 8.0
Min, Max 0, 10 0, 10 0, 10 0, 10

Sexual Desire Optilume BPH (N=98)
n 97 92 91 89
Mean ± SD 6.3 ± 2.2 6.5 ± 2.1 6.6 ± 2.2 6.5 ± 2.2
Median 6.0 7.0 7.0 7.0
Min, Max 2, 10 2, 10 2, 10 2, 10
Sham (N=48)
n 48 47 35 26
Mean ± SD 6.4 ± 1.9 6.1 ± 1.8 6.3 ± 1.7 6.4 ± 2.0
Median 7.0 6.0 6.0 6.5
Min, Max 2, 10 2, 9 3, 10 2, 10
Overall Optilume BPH (N=98)
Satisfaction n 96 92 91 86
Mean ± SD 5.6 ± 2.7 6.2 ± 2.8 6.3 ± 2.9 6.3 ± 2.9
Median 6.0 6.0 6.0 6.0
Min, Max 2, 10 2, 10 2, 10 2, 10
Sham (N=48)
n 47 45 35 26
Mean ± SD 5.4 ± 2.7 5.9 ± 2.8 6.4 ± 2.8 6.5 ± 2.8
Median 5.0 6.0 6.0 6.5
Min, Max 2, 10 2, 10 2, 10 2, 10
Note: A higher score indicates higher sexual function.
Table 13. MSHQ-EjD Over Time (As Observed)

Ejaculatory Optilume BPH (N=98)
Function1 n 98 86 87 87
Mean ± SD 7.5 ± 3.9 8.5 ± 4.8 8.3 ± 4.5 8.4 ± 4.6
Median 7.0 9.0 9.0 9.0
Min, Max 1, 15 1, 15 1, 15 1, 15
Sham (N=48)
n 47 47 35 26
Mean ± SD 8.0 ± 3.4 8.8 ± 3.9 9.1 ± 3.4 9.9 ± 3.5
Median 8.0 9.0 10.0 10.0
Min, Max 1, 15 1, 15 1, 15 4, 15
Ejaculation Optilume BPH (N=98)
Bother2 n 98 86 87 87
Mean ± SD 2.5 ± 1.7 1.9 ± 1.6 2.1 ± 1.7 2.0 ± 1.7
Median 3.0 2.0 2.0 2.0
Min, Max 0, 5 0, 5 0, 5 0, 5
Sham (N=48)
n 47 47 35 26
Mean ± SD 2.2 ± 1.7 2.0 ± 1.5 2.1 ± 1.6 2.0 ± 1.8
Median 2.0 2.0 2.0 1.5
Min, Max 0, 5 0, 5 0, 5 0, 5
1Higher score = Less ejaculation dysfunction (Possible Range 1 - 15)
2Higher score = Greater bother with ejaculation difficulties (Possible Range 0 - 5)

Ancillary Endpoint 4 – Change in BPH Impact Index (BPH-II)
Table 14. BPH Impact Index Over Time (As Observed)

Group Baseline 30 Day 3 Month 6 Month 12 Month
Optilume BPH (N=98)
n 98 96 93 91 89
Mean ± SD 7.0 ± 2.9 5.3 ± 3.2 4.5 ± 3.2 2.9 ± 2.8 2.3 ± 2.5
Median 7.0 5.0 4.0 2.0 2.0
Min, Max 1, 12 0, 13 0, 12 0, 12 0, 11
Sham (N=48)
n 48 48 48 35 26
Mean ± SD 7.0 ± 3.0 3.8 ± 3.1 3.9 ± 3.5 3.6 ± 2.7 3.4 ± 3.1
Median 7.0 3.0 3.0 4.0 3.0
Min, Max 0, 12 0, 13 0, 12 0, 9 0, 12
Ancillary Endpoint 5 – Change in Quality of Life (EQ-5D)
Table 15. EQ-5D Composite Over Time (As Observed)

Measure Baseline 30 Day 3 Month 6 Month 12 Month
Optilume BPH (N=98)
n 98 96 93 90 88
Mean ± SD 0.865 ± 0.123 0.866 ± 0.116 0.875 ± 0.120 0.888 ± 0.132 0.878 ± 0.132
Median 0.861 0.861 0.861 0.876 0.876
Min, Max 0.49, 1.00 0.39, 1.00 0.38, 1.00 0.46, 1.00 0.46, 1.00
Sham (N=48)
n 48 47 47 35 26
Mean ± SD 0.854 ± 0.108 0.900 ± 0.106 0.893 ± 0.101 0.886 ± 0.096 0.887 ± 0.099
Median 0.854 0.876 0.876 0.861 0.861
Min, Max 0.51, 1.00 0.49, 1.00 0.62, 1.00 0.72, 1.00 0.72, 1.00
Table 16. EQ-5D VAS Over Time (As Observed)

Measure Baseline 30 Day 3 Month 6 Month 12 Month
Optilume BPH (N=98)
n 98 96 93 90 88
Mean ± SD 81.6 ± 14.4 82.6 ± 13.9 85.8 ± 11.4 84.6 ± 14.0 86.5 ± 10.0
Median 85.0 87.5 90.0 89.0 89.0
Min, Max 25, 100 40, 100 40, 100 10, 100 45, 100
Sham (N=48)
n 48 47 47 35 26
Mean ± SD 78.9 ± 13.7 83.5 ± 11.0 83.1 ± 10.4 82.8 ± 7.9 84.3 ± 8.9
Median 80.0 85.0 85.0 85.0 85.0
Min, Max 30, 100 50, 100 50, 100 70, 95 57, 100

Ancillary Endpoint 6 – Change in Pain Score
Table 17. Peri-operative VAS Pain Scores (As Observed)

Group Baseline Procedure Foley Removal 14 Day 30 Day 3 Month
Optilume BPH (N=98)
n 98 97 96 95 97 94
Mean ± SD 1.2 ± 2.0 4.1 ± 2.3 2.4 ± 2.2 1.6 ± 1.9 1.4 ± 1.8 1.1 ± 1.6
Median 0.0 4.0 2.0 1.0 1.0 0.0
Min, Max 0, 8 0, 10 0, 10 0, 9 0, 8 0, 6
Sham (N=48)
n 48 48 48 47 48 48
Mean ± SD 1.3 ± 2.0 2.6 ± 1.9 2.8 ± 2.5 0.9 ± 1.6 0.6 ± 1.3 0.9 ± 1.6
Median 0.0 3.0 2.0 0.0 0.0 0.0
Min, Max 0, 7 0, 7 0, 8 0, 8 0, 6 0, 8
Ancillary Endpoint 7 – Procedure Parameters

Procedures were performed in an ambulatory surgical center (81.5%) or office-based location
(18.5%). The average (SD) time for the Optilume BPH procedure from cystoscope insertion to
removal of the treatment device was 26.0 (8.2) minutes (n=98).
Ancillary Endpoint 9 – Proportion of Subjects Experiencing a Return to ‘Normal’
Symptom Severity (IPSS<8)
Approximately one-third of subjects (30.9%, 29/94) treated with the Optilume BPH Catheter
System returned to ‘normal’ symptom levels by 12 months post-treatment compared to 14.6%
(7/48) in the Control group.
Table 18. Proportion of Subjects with IPSS<8

Proportion of Subjects with IPSS <8
Visit
Optilume BPH Sham
3 Month
% (n/N) 25.0% (24/96) 20.8% (10/48)
95% CI1 16.7%, 34.9% 10.5%, 35.0%
6 Month
% (n/N) 29.8% (28/94) 8.5% (4/47)
95% CI1 20.8%, 40.1% 2.4%, 20.4%
12 Month
% (n/N) 30.9% (29/94) 14.6% (7/48)
95% CI1 21.7%, 41.2% 6.1%, 27.8%
Note: Timepoints after study exit due to treatment failure or crossover to treatment are imputed as failures
1
Confidence intervals (CI) are estimated using the Clopper-Pearson (exact) approach.
12.1.4 Safety Outcomes

The primary safety endpoint of the PINNACLE study was defined as the proportion of subjects
experiencing a composite of major device-related serious complications through 12 months
post-procedure: rectal or gastrointestinal fistula, fistula between the rectum and urethra, new
onset severe urinary retention lasting >14 consecutive days post-healing, unresolved de novo
stress urinary incontinence by 90 days, bleeding requiring transfusion, and urethra or prostatic
capsule rupture requiring surgical intervention. No subjects experienced an event qualifying for
the pre-defined composite of serious device-related complications through 12 months as
adjudicated by the Clinical Events Committee (CEC).

Table 14. Primary Safety Endpoint – Freedom from Major Device Related Complications
Sham Optilume BPH Difference
Endpoint (n=48) (n=100) (95% CI)
Major device-related complications at 12 0.0%
0.0% (0/48) 0.0% (0/100)
months (0.0%, 0.0%)
Adverse event summaries are based on the As-Treated cohort which included 98 subjects in the
Optilume BPH arm treated with the device (Table 19). A summary of events adjudicated by the
CEC as related to the study device or procedure is shown in Table 20.
Table 19. Summary of Adverse Events by Arm (As Treated)

Optilume BPH (N=98) Sham (N=48)
Participant % Participant %
Event Types Events (n/N) Events (n/N)
Adverse Events 241 82.7% (81/98) 58 62.5% (30/48)
Serious Adverse Events 15 14.3% (14/98) 3 6.3% (3/48)
Treatment Related Adverse Events 143 71.4% (70/98) 15 25.0% (12/48)
Device Related AE 121 67.3% (66/98) 11 16.7% (8/48)
Procedure Related AE 22 18.4% (18/98) 4 8.3% (4/48)
Treatment Related Serious Adverse Events 6 6.1% (6/98) 0 0.0% (0/48)
Device Related SAE 5 5.1% (5/98) 0 0.0% (0/48)
Procedure Related SAE 1 1.0% (1/98) 0 0.0% (0/48)
Treatment-related serious adverse events were reported in 6 (6.1%) subjects, most commonly
post-procedure hematuria (4 events) which resolved without sequelae. The most frequently
reported treatment-related adverse events included hematuria (39.8%), urinary tract infection
(11.2%), dysuria (8.2%), and mild stress urinary incontinence (7.1%). Treatment-related
adverse events were mostly mild or moderate in severity (138/143, 97%). There were no life
threatening (Grade 4) or fatal (Grade 5) events related to either the study device or procedure.
A total of 41 hematuria and post-procedural hematuria events occurred in 39 subjects (39.8%)
with most events being mild or moderate in severity (37/41, 90.2%) with a median time to
resolution of 34 days. The rate and severity of hematuria events was decreased after
implementation of post-operative care guidelines as described in section 11.6.
Table 20. Device/Procedure Related Adverse Events (As Treated)

System Organ Class/ Grade 1-2 Grade 3 Grade 1-2 Grade 3
CTC Term Participant Participant Participant Participant
Events % (n/N) Events % (n/N) Events % (n/N) Events % (n/N)
Gastrointestinal Disorders 0 0.0% (0/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Abdominal pain 0 0.0% (0/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
General Disorders And 0 0.0% (0/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Administration Site Conditions
Fever 0 0.0% (0/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Infections And Infestations 12 11.2% (11/98) 0 0.0% (0/98) 4 6.3% (3/48) 0 0.0% (0/48)
Bladder infection 0 0.0% (0/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Urinary tract infection 12 11.2% (11/98) 0 0.0% (0/98) 3 4.2% (2/48) 0 0.0% (0/48)

Injury, Poisoning And 0 0.0% (0/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Procedural Complications
Investigations 2 2.0% (2/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Elevated prostate specific 2 2.0% (2/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
antigen [PSA]
Musculoskeletal And 2 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Connective Tissue Disorders
Groin pain 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Low back pain 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Product Issues 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Catheter blockage 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Renal And Urinary Disorders 99 65.3% (64/98) 5 5.1% (5/98) 7 12.5% (6/48) 0 0.0% (0/48)
Bladder cancer 0 0.0% (0/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Bladder perforation 0 0.0% (0/98) 1 1.0% (1/98) 0 0.0% (0/48) 0 0.0% (0/48)
Bladder spasm 6 6.1% (6/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Dysuria 8 8.2% (8/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Frequency of micturition 3 3.1% (3/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Hematuria 11 10.2% (10/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Leukocyturia 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Lower urinary tract symptoms 5 4.1% (4/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Meatal stenosis 1 1.0% (1/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Nocturia 3 3.1% (3/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Overactive bladder 2 2.0% (2/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Post micturition dribble 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Post procedural hematuria 26 25.5% (25/98) 4 4.1% (4/98) 0 0.0% (0/48) 0 0.0% (0/48)
Stress urinary incontinence 7 7.1% (7/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Urethral false passage 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Urethral pain 2 2.0% (2/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Urethral stricture 4 4.1% (4/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Urethritis 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Urinary incontinence 5 5.1% (5/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
(Urge/Mixed)
Urinary retention 3 3.1% (3/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Urinary urgency 6 6.1% (6/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Voiding difficulty 3 2.0% (2/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Reproductive System And 21 15.3% (15/98) 0 0.0% (0/98) 2 4.2% (2/48) 0 0.0% (0/48)
Breast Disorders
Anejaculation 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Ejaculation decreased 1 1.0% (1/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Epididymitis 0 0.0% (0/98) 0 0.0% (0/98) 1 2.1% (1/48) 0 0.0% (0/48)
Hematospermia 4 4.1% (4/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Painful ejaculation 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Painful orgasm 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Pelvic pain 6 5.1% (5/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Penile pain 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Perineal pain 3 3.1% (3/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Prostatitis 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Retrograde ejaculation 2 2.0% (2/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)

Respiratory, Thoracic And 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
Mediastinal Disorders
Aspiration pneumonia 1 1.0% (1/98) 0 0.0% (0/98) 0 0.0% (0/48) 0 0.0% (0/48)
12.1.5 Pharmacokinetic Profile

A sub-study including 15 non-randomized subjects was conducted to determine the
pharmacokinetic profile of paclitaxel in blood (plasma), urine, and semen after treatment with
the Optilume BPH DCB. Determination of plasma paclitaxel concentration was evaluated
immediately after completion of the procedure, at 1, 3, and 5 hours, and at Foley removal, 30
days, 3 months, and 6 months post-procedure. Urine paclitaxel concentration was evaluated
immediately post-procedure, at Foley removal, and at 30 days, 3 months, and 6 months. Semen
paclitaxel concentration was evaluated at 30 days, 3 months, and 6 months post-procedure.
A summary of pharmacokinetic parameters, including maximum concentration (Cmax) and time
to maximum concentration (Tmax) for plasma is in Table 21. Paclitaxel concentration over time in
urine and semen can be found in Table 22 and Table 23, respectively. On average, paclitaxel
concentration in plasma fell below the limit of quantitation of the method (0.10 ng/mL or 0.1 part
per billion) by the time of Foley removal, while average paclitaxel concentration in urine
approached the limit of quantitation by 6 months. Analysis of paclitaxel concentration in semen
showed low but persistent levels of paclitaxel in semen through 6 months post-treatment. Of the
three subjects who had evaluable data at 12 months post-treatment, one had detectable
paclitaxel concentration in semen (0.16 ng/mL).
Table 21. Summary of Plasma Pharmacokinetic Parameters

Parameter Plasma
Cmax (ng/mL)
n 15
Mean 0.40 ± 0.54
Min, Max <0.10, 2.24
Tmax (hr)
n 15
Median 1.0 ± 1.71
Min, Max 0.25, 5
Table 22. Urine Paclitaxel Concentration Over Time

Urine Paclitaxel Concentration (ng/mL)
Measure Foley
Baseline 0hr 30 Days 3 Months 6 Months
Removal
1,892.8 ± 134.6 ±
Mean ± SD <0.1 ± 0.0 1.3 ± 1.5 0.4 ± 0.7 0.1 ± 0.2
4,530.6 221.9
Median <0.1 536.5 65.1 0.7 0.2 <0.1
Max, Min <0.1 17,500, 64.4 841, 3.6 5.5, <0.1 2.8, <0.1 0.6, <0.1
Subjects with 0/13 14/14 13/13 12/14 9/14 3/15
Measurable Amt (0.0%) (100.0%) (100.0%) (85.7%) (64.3%) (20.0%)

Table 23. Semen Paclitaxel Concentration Over Time
Semen Concentration (ng/mL)
Measure
Baseline 30 Days 3 Months 6 Months 12 Months
Mean ± SD <0.10 ± 0.0 2.34 ± 3.69 1.30 ± 2.76 0.29 ± 0.53 0.09 ± 0.06
Median <0.10 0.86 0.27 <0.10 <0.10
Max, Min <0.10 8.89, <0.10 7.54, <0.10 1.75, <0.10 0.16, <0.10
Subjects with 0/6 4/5 5/7 4/10 1/3Į
Measurable Amt (0.0%) (80.0%) (71.4%) (40.0%) (33.3%)
ĮOnly subjects with confirmed or suspected paclitaxel present in their semen at 6 months were required to
provide 12-month semen samples.
12.2 Supplemental Clinical Study

EVEREST-I was a prospective, non-randomized, open label, multicenter study to evaluate the
safety and efficacy of the Optilume BPH Catheter system for the treatment of LUTS secondary
WR%3+(OLJLEOHVXEMHFWVZHUHPHQ!\HDUVRIDJHZLWK/876VHFRQGDU\WR%3+,366
peak urinary flow rate 5-15 mL/sec, post-YRLGUHVLGXDOP/SURVWDWHYROXPH-80 grams,
and prostatic urethral length 35-55 mm. Key exclusions included prior minimally invasive or
surgical intervention of the prostate, intravesical prostatic protrusion >1 cm, and confounding
urologic conditions (e.g., neurogenic bladder, stricture). Subjects had to undergo drug washouts
prior to treatment including alpha blockers for 3 weeks and 5-alpha reductase inhibitors for 6
months. Subjects were followed at Foley removal, 2 weeks, 30 days, 3 months, 6 months, and
1-year post-treatment, and annually thereafter through 3 years. Follow-up is planned through 5
years.
A total of 80 subjects were enrolled and treated at 6 clinical sites in Panama and the Dominican
Republic. Subjects were 65 years old on average with a prostate volume of 35.9 grams. The
primary efficacy endpoint was the responder rate at 3 months based on an improvement in
,366IURPEDVHOLQHZLWKRXWUHTXLULQJDGGLWLRQDOWKHUDS\$WPRQWKV
were considered responders with a lower 90% confidence limit of 72.6% which met the
performance goal of 50%.
Table 24. EVEREST-I Results Summary

Measure Baseline 3 months 6 months 1 year 2 years 3 years
IPSS
n 80 79 77 75 68 63
Mean ± SD 22.3 ± 4.9 8.1 ± 6.1 8.0 ± 7.2 7.9 ± 7.6 8.2 ± 7.3 9.8 ± 8.0
IPSS QoL
n 80 79 77 75 68 63
Mean ± SD 4.6 ± 0.86 1.5 ± 1.33 1.6 ± 1.62 1.3 ± 1.38 1.6 ± 1.58 1.8 ± 1.74
Qmax (mL/sec)
n 80 77 74 74 56 58
Mean ± SD 10.9 ± 2.92 20.5 ± 9.54 19.6 ± 8.67 18.4 ± 8.21 17.2 ± 8.98 16.7 ± 10.63
PVR (mL)
n 80 77 74 74 56 58
Mean ± SD 63.1 ± 55.01 34.3 ± 33.08 28.8 ± 29.53 34.4 ± 35.25 45.0 ± 50.94 49.1 ± 79.29
The primary safety endpoint was a composite of device and procedure related serious
complications at 3 months including new onset severe urinary retention lasting >14 consecutive
days post-healing, unresolved new onset stress urinary incontinence by 90 days, and bleeding
requiring transfusion. Two subjects experienced stress urinary incontinence meeting the

endpoint criteria for a rate of 2.5%. Both subjects were treated with a larger diameter balloon
that is no longer included in the matrix of available device sizes.
13 WARRANTY
Urotronic warrants that reasonable care has been used in the design and manufacture of this
product. This warranty is in lieu of and excludes all other warranties not expressly set forth
herein, whether express or implied by operation of law or otherwise, including, but not limited to,
any implied warranties for a particular purpose. Handling, storage, cleaning, and sterilization of
this device as well as other factors relating to the patient, diagnosis, treatment, surgical
procedures and other matters beyond Urotronic’s control directly affect the device and the
results obtained from its use. Urotronic’s obligation under this warranty is limited to the repair or
replacement of this device and Urotronic shall not be liable for any incidental or consequential
loss, damage or expense directly or indirectly arising from the use of this device. Urotronic
assumes no liability with respect to devices reused, reprocessed or resterilized and makes no
warranties, express or implied, including but not limited for a particular purpose, with respect to
such devices.
Urotronic, Inc.
2495 Xenium Lane North
Minneapolis, MN 55441 USA
www.urotronic.com

14 SYMBOLS USED IN THE DEVICE LABELS
Quantity of 1 per box
Caution: Federal law restricts this device to sale by or on the order of a physician
Catalogue number
Lot number
Date of manufacture
Do not resterilize
Do not re-use
Do not use if package is damaged
Fragile
Use-by date
Keep away from sunlight
Keep dry
Manufacturer
Does not contain latex
Temperature limit 15°C - 30°C (59°F - 86°F)
Caution: Consult instructions for use
Sterilized using ethylene oxide
Single sterile barrier system
Single sterile barrier system with protective packaging outside
Medical device
Unique device identifier
Contains a medicinal substance

Optilume FDA Approval

Uploaded by

Copyright:

Available Formats

Optilume FDA Approval

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Optilume FDA Approval

Uploaded by

Copyright:

Available Formats

Instructions for Use

Page 1 of 30 1124-004 rA Draft

1 DEVICE DESCRIPTION ...................................................................................................................... 3

Page 2 of 30 1124-004 rA Draft

Figure 1. Inflated Pre-dilation Balloon Catheter

Figure 2. Inflated Drug Coated Balloon Catheter

Page 3 of 30 1124-004 rA Draft

1.2 Available Sizes and Nominal Paclitaxel Dose

Table 2. DCB Sizes and Nominal Paclitaxel Dose

2 INDICATIONS FOR USE

Page 4 of 30 1124-004 rA Draft

Page 5 of 30 1124-004 rA Draft

Page 6 of 30 1124-004 rA Draft

Page 7 of 30 1124-004 rA Draft

Page 8 of 30 1124-004 rA Draft

Figure 3. Mid-sagittal TRUS Image Showing PUL Measurement

Table 3: Optilume BPH DCB Size Selection

11.3 Balloon Preparation

Page 9 of 30 1124-004 rA Draft

Page 10 of 30 1124-004 rA Draft

Figure 4. Positioning of the Balloon Within the Prostatic Urethra

Page 11 of 30 1124-004 rA Draft

Page 12 of 30 1124-004 rA Draft

12 SUMMARY OF CLINICAL STUDIES

Page 13 of 30 1124-004 rA Draft

Table 4. Visit Compliance for Randomized Cohort

Page 14 of 30 1124-004 rA Draft

12.1.2 Study Population Demographics and Baseline Parameters

Table 5. Demographics and Genitourinary Medical History

Page 15 of 30 1124-004 rA Draft

Page 16 of 30 1124-004 rA Draft

12.1.3 Efficacy Outcomes

Table 7. Primary Efficacy Endpoint – Improvement in IPSS (ITT, Multiple Imputation)

Page 17 of 30 1124-004 rA Draft

Table 8. Comparison of Literature Sham Improvement in IPSS at 3 Months to Optilume

12.1.3.2 Secondary Endpoints

Table 9. Secondary Endpoint 1 – Average IPSS Improvement at 12 Months

Table 10. Secondary Endpoint 2 – Responder Rate at 3 Months

Page 18 of 30 1124-004 rA Draft

Table 11. Secondary Endpoint 3 – Responder Rate at 12 Months

Secondary Endpoint 4 – Change in Qmax

Table 12. Secondary Endpoint 4 Change in Qmax from Baseline

12.1.3.3 Ancillary Endpoints

Page 19 of 30 1124-004 rA Draft

Page 20 of 30 1124-004 rA Draft

Ancillary Endpoint 3 – Change in Sexual Function (International Index of Erectile

Table 12. IIEF Over Time (As Observed)

Page 21 of 30 1124-004 rA Draft

Table 13. MSHQ-EjD Over Time (As Observed)

Page 22 of 30 1124-004 rA Draft

Table 14. BPH Impact Index Over Time (As Observed)

Ancillary Endpoint 5 – Change in Quality of Life (EQ-5D)

Table 15. EQ-5D Composite Over Time (As Observed)

Table 16. EQ-5D VAS Over Time (As Observed)

Page 23 of 30 1124-004 rA Draft

Table 17. Peri-operative VAS Pain Scores (As Observed)

Ancillary Endpoint 7 – Procedure Parameters

Table 18. Proportion of Subjects with IPSS<8

12.1.4 Safety Outcomes