world class

Medical TEXTILEs
uc to l a n o s r e p e th h it w d elivere d h

Technical Information

[email protected] www.oem.vascutek.com

World class medical textiles

For over 30 years, VASCUTEK, a TERUMO Company has been delivering World Class Medical Textiles to our OEM partners. Vascutek delivers world class textiles that are trusted by medical professionals for their quality and reliability. The Vascutek OEM team works in close cooperation at every stage from initial product concept through to final component supply.

Experience where it counts

WORLD CLASS People at the heart of your success

Our team of specialist textile technicians has over 200 years of combined textile manufacturing experience. They have developed custom equipment and processes to create some of the most innovative technical textiles in clinical use today.

Vascutek is one of the worlds leading manufacturers of implantable medical textiles. We design and develop textile products that address the fundamental needs of our worldwide customer base.

Our team is passionate about creating world class medical textiles for our OEM partners. No request is too big or too small we always do our utmost to fulfil our customers needs in an efficient, professional and friendly manner.

Our philosophy is simple: Whatever our customer wants, we will do our best to provide.

Vascutek - a history of world class innovation Vascutek has been delivering innovative world class medical textiles for over 30 years. Our products are known worldwide for their quality, consistency and reliability. We are recognized for our innovative textile products: Gelweave - the conduit of choice for LVADS Gelsoft Plus - a unique Kper knitted structure to dramatically reduce graft dilatation 1,2 Gelweave Valsalva closely matches aortic root anatomy 3 Equi-flo - symmetrical bifurcated flowsplitter design provides equal flow to both legs 4

World class excellence in technology & innovation

Vascutek products specified by medical professionals worldwide Medical professionals worldwide specify Vascutek textile products because of their superior handling characteristics. Your medical device will benefit from utilizing the most trusted and innovative implantable textile designs available. Vascutek - we link our core technologies to your product applications Vascutek Core Technologies Knitting Weaving Product modification and customization of standard designs Sterilization

Vascutek - a world class manufacturing facility Vascutek operates an ISO 9001:2008 and ISO 13485:2003 manufacturing facility in Scotland. Our company is certified by the British Standards Institute (BSI). Vascutek offers our expertise in medical textiles to our OEM partners. We have available a vast range of standard and customized products. These are offered either as a sub assembly or as a complete sterile component. We also provide additional finishing services such as component assembly and sterilization.

Let us know your requirements and we will make it a reality

Quality is THE KEY TO OUR SUCCESS

Quality Vascutek has developed the systems to work with OEM partners and integrate them into our quality management system. Vascutek is certified to ISO 9001:2008 and ISO 13485:2003. Vascutek can also conduct contract ETO sterilization for our OEM partners and we are certified to ISO 11135-1:2007. Regulatory support The majority of our standard products are approved in the USA, Canada, Europe, Japan & Australasia. We supply a wide range of regulatory support to our OEM partners. Packaging services Our in-house packaging consultants offer a full line design and fulfilment service. All aspects of customer specific packaging can be accommodated including custom pack design, CAD drawings, IFU preparation and translation, and label artwork. Furthermore, we offer OEM generic packaging for small volume purchases and validation purposes.

Let us know what you need and we will deliver.

Woven Polyester
Twillweave Gelweave
Advanced fully texturized woven structure Excellent dimensional stability Floating yarns create a velour on the external surface Excellent handling 2,3 Comprehensive standard product range available Externally supported and branch designs available Gelatin sealed option (Gelweave)

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Woven structure Standard Diameters : Straight : 6 - 38 mm Bifurcate : 12 mm x 6 mm, 14 mm x 7 mm, 16 mm x 8 mm, 18 mm x 9 mm, 20 mm x 10 mm, 22 mm x 11 mm, 24 mm x 12 mm Standard Lengths : Straight crimped : 1 - 60 cm Straight uncrimped : 1 - 100 cm Bifurcate crimped : 45 cm Wall Thickness : All configurations (crimped)- 0.52 mm All configurations (uncrimped)- 0.312 mm Dilatation : All configurations- 3.88 % Suture Retention : All configurations- 26 N or 2651 g Burst Strength : All configurations- 472 N Water Permeability : All configurations - 358 ml/cm2/min

Twillweave

Advanced fully texturized woven structure

Gelweave

[email protected]
Uncrimped Twillweave
Advanced fully texturized woven structure for endovascular applications Excellent dimensional stability Floating yarns create a velour on the external surface Excellent handling 2,3 Comprehensive standard product range available

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Woven structure Standard Diameters : Straight : 6 - 38 mm Bifurcate : 12 mm x 6 mm, 14 mm x 7 mm, 16 mm x 8 mm, 18 mm x 9 mm, 20 mm x 10 mm, 22 mm x 11 mm, 24 mm x 12 mm Standard Lengths : Straight crimped : 1 - 60 cm Straight uncrimped : 1 - 100 cm Bifurcate crimped : 45 cm Wall Thickness : All configurations (uncrimped)- 0.158 mm Dilatation : All configurations- 3.88 % Suture Retention : All configurations- 18.82 N or 1919 g Burst Strength : All configurations- 412 N Water Permeability : All configurations - 192 ml/cm2/min

Advanced fully texturized woven structure for endovascular applications

Uncrimped Twillweave

Woven Polyester
Woven Endovascular Fabric
Thin Wall Endovascular Fabric Low thrombogenicity woven polyester Tapered bifurcate and straight configurations available Ideal fabric for endovascular stent grafts

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Woven structure Standard Diameters : Straight : 8 - 40 mm Bifurcate : 18 - 32 mm Standard Lengths : Straight : up to 250 mm Bifurcate : up to 175 mm Wall Thickness : Straight : Mean - 0.14 mm Standard Deviation - 0.012 mm Bifurcate : Mean - 0.15 mm Standard Deviation - 0.014 mm Suture Retention : All configurations- 25 N or 2549 g Burst Strength : All configurations- 155 N Water Permeability : Straight : - 346 ml/cm2/min Bifurcate : - 490 ml/cm2/min

using Vascutek Thin Wall Endovascular Fabric

Anaconda AAA device

[email protected]
using Vascutek Thin Wall Endovascular Fabric

Anaconda ONE-LOK

Anaconda AAA device flexible leg

using Vascutek Thin Wall Endovascular Fabric

Knitted Polyester
VP1200K Gelsoft
Conventional warp lock knitted structure Comprehensive standard product range available Externally supported and branch designs available Superb handling 1 Gelatin sealed option (Gelsoft)

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Conventional warp lock knitted polyester structure Standard Diameters : Straight : 2 - 24 mm Bifurcate : 10 mm x 5 mm , 12 mm x 6 mm, 14 mm x 7 mm, 16 mm x 8 mm, 18 mm x 9 mm 20 mm x 10 mm, 22 mm x 11 mm, 24 mm x 12 mm Standard Lengths : Straight crimped : 1 - 60 cm Straight uncrimped : 1 - 100 cm Bifurcate crimped : 45 or 50 cm Wall Thickness : All configurations (crimped)- 0.653 mm All configurations (uncrimped)- 0.551 mm Suture Retention : All configurations- 29.53 N or 3011 g Burst Strength : All configurations- 198 N Water Permeability : All configurations - 1833 ml/cm2/min

using Conventional warp lock knitted structure

VP1200K Gelsoft

[email protected]
Gelseal
Conventional warp lock knitted structure Strong & stable polyester matrix achieved by incorporating an extra set of yarns Comprehensive standard product range available Externally supported and branch designs available Superb handling 1

Technical Specification

Base Material : Textured polyester yarn Type of Construction : Conventional warp lock knitted structure Standard Diameters : Straight : 4 - 38 mm Bifurcate : 12 mm x 6 mm, 14 mm x 7 mm 16 mm x 8 mm, 18 mm x 9 mm 20 mm x 10 mm, 22 mm x 11 mm 24 mm x 12 mm Standard Lengths : Straight crimped : 1 - 60 cm Straight uncrimped : 1 - 100 cm Bifurcate crimped : 45 cm Wall Thickness : All configurations (crimped)- 0.731 mm All configurations (uncrimped)- 0.512 mm Suture Retention : All configurations- 40.03 N or 4082 g Burst Strength : All configurations- 332 N Water Permeability : All configurations - 1466 ml/cm2/min

using Conventional warp lock knitted structure

Gelseal

Knitted Polyester
Unique Kper knitted structure

VP1200K Plus Gelsoft Plus

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Kper Knit structure Standard Diameters : Straight : 4 - 24 mm Bifurcate : 12 mm x 6 mm, 14 mm x 7 mm 16 mm x 8 mm, 18 mm x 9 mm 20 mm x 10 mm, 22 mm x 11 mm 24 mm x 12 mm Standard Lengths : Straight crimped : 1 - 60 cm Straight uncrimped : 1 - 100 cm Bifurcate crimped : 45 cm Wall Thickness : All configurations (crimped)- 0.65 mm All configurations (uncrimped)- 0.489 mm Dilatation : All configurations- 5.5 % Suture Retention : All configurations- 37.75 N or 3849 g Burst Strength : All configurations- 434 N Water Permeability : All configurations - 2543 ml/cm2/min

Dramatically reduced dilatation1, 2 Soft handling Absence of fraying Increased strength and suture retention Comprehensive standard product range available Externally supported and branch designs available Gelatin sealed option (Gelsoft Plus)

VP1200K Patch Gelsoft Plus Patch

Conventional warp lock knitted structure Comprehensive standard product range available Superb handling 1 Gelatin sealed option (Gelsoft Plus Patch)

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Conventional warp lock knitted polyester structure Standard Diameters : 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22 and 24 mm Standard Lengths : As required Wall Thickness : All configurations - 0.456 mm Suture Retention : All configurations- 26.04 N or 2655 g Burst Strength : All configurations- 198 N Tensile Strength : All configurations- 175 N Water Permeability : All configurations - 1715.5 ml/cm2/min

[email protected]
Thin Wall Kper Knit
Unique thin wall Kper knitted structure Dramatically reduced dilatation1, 2 Soft handling Absence of fraying Increased strength and suture retention Externally supported designs available Gelatin sealed option

Technical Specification

Base Material : Textured polyester yarn Type of Construction : Kper knit structure Standard Diameters : Straight : 5, 6, 7, 8, 9, 10 &11 mm Standard Lengths : Straight crimped : 1 - 80 cm Straight uncrimped : 1 - 100 cm Bifurcate crimped : 45 cm Wall Thickness : Crimped- 0.41 mm Dilatation : All configurations- 9.7 % Suture Retention : All configurations- 20.78 N or 2119 g Burst Strength : All configurations- 200 N Water Permeability : All configurations - 3536 ml/cm2/min

using Vascutek Thin Wall Kper knitted structure

K-Thin

Knitted Polyester
DLT1 Fabric
Heart valve sewing ring material Knitted polyester fabric structure Ideal for heart valve cuff sewing ring Unique fluoropassivation option available

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Knitted structure Standard Diameters : 16, 18, 20, 22, 24, 26, 28, 30 and 32 mm Standard Lengths : Straight : 10 -100 cm Wall Thickness : All configurations- 0.299 mm Suture Retention : All configurations- 14.48 N or 1476 g Burst Strength : All configurations- 141 N Water Permeability : All configurations - 1.668 ml/cm2/min

DTH2 Fabric
Heart valve sewing ring material Knitted polyester fabric structure Ideal for heart valve cuff sewing ring Unique fluoropassivation option available

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Knitted structure Standard Diameters : 8, 10, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 and 38 mm Standard Lengths : As required Wall Thickness : All configurations- 0.466 mm Suture Retention : All configurations- 25.18 N or 2567 g Burst Strength : All configurations- 246 N Water Permeability : All configurations - 0.960 ml/cm2/min

[email protected]
Drug Pump Pouch
Highly porous knitted structure Knitted polyester fabric structure Ideal for drug delivery systems

Technical Specification
Base Material : Textured polyester yarn Type of Construction : Conventional warp lock knitted polyester structure Standard Diameter : 26 mm Standard Lengths : Straight : 10 -100 cm Wall Thickness : All configurations- 0.386 mm Suture Retention : All configurations- 16.16 N or 1648 g Burst Strength : All configurations- 180 N Water Permeability : N/A

using Vascutek DTL 1 and DTH 2 Fabrics

Heart valve products

Expanded PTFE

ePTFE Ultrathin Wall

Ultrathin wall expanded PTFE Low thrombogenicity expanded PTFE material Double layer porous ePTFE wrap available Soft, flexible and compliant construction Gelatin sealed option

Technical Specification
Base Material : PTFE fine powder Type of Construction : Base tube and helical outer wrap Uniaxially expanded 15 +/- 5 micron internodal distance Standard Diameters : 5 - 10 mm Standard Lengths : 10 - 80 cm Wall Thickness : Unwrapped > 0.38mm Wrapped > 0.32mm Suture Retention : 5 mm 1.5 N All other diameters 2 N Burst Strength : 1600 mmHg Tensile Strength : 100 N Water Entry Pressure : 250 mmHg

ePTFE Standard Wall

Standard wall expanded PTFE Low thrombogenicity expanded PTFE material Double layer porous ePTFE outer wrap available Soft, flexible and compliant construction Gelatin sealed option

Technical Specification
Base Material : PTFE fine powder Type of Construction : Base tube and helical outer wrap Uniaxially expanded 15 +/- 5 micron internodal distance Standard Diameters : 5 - 10 mm Standard Lengths : 10 - 80 cm Wall Thickness : Unwrapped > 0.48mm Wrapped > 0.47mm Suture Retention : 5 mm 1.5 N All other diameters 3 N Burst Strength : 1600 mmHg Tensile Strength : 100 N Water Entry Pressure : 250 mmHg

[email protected]
ePTFE Tapered
Short taper and Stepped taper Low thrombogenicity expanded PTFE material Double layer porous ePTFE outer wrap available Soft, flexible and compliant construction Gelatin sealed option

Technical Specification
Base Material : PTFE fine powder Type of Construction : Base tube and helical outer wrap Uniaxially expanded 15 +/- 5 micron internodal distance Standard Diameters : Short Taper Small Diameter : 4 mm Large Diameter : 6 and 7 mm Standard Lengths : 30, 45 and 50 cm Standard Diameters : Stepped Taper Small Diameter : 4 and 5 mm Large Diameter : 6, 7 and 8 mm Standard Lengths : 20, 25, 30, 35, 40, 45 and 50 cm Wall Thickness : Unwrapped: Small Diameter: > 0.44mm Large Diameter: > 0.11mm Wrapped: Small Diameter: > 0.49mm Large Diameter: > 0.19mm Suture Retention : Small Diameter : 1.5 N Large Diameter : 1.5 N Burst Strength : 1600 mmHg Tensile Strength : 100 N Water Entry Pressure : 250 mmHg

ePTFE Outer Wrap

Ultrathin wall sintered ePTFE tape in tubular form Ideal for applications such as: Covered Peripheral Stents AAA Stents TAA Stents

Technical Specification
Base Material : PTFE fine powder 12 mm ePTFE tape Type of Construction : Single layer of ePTFE tape wound onto a mandrel with a 2 mm overlap Standard Diameters : 30 and 35 mm Also available: 10, 20, 25, 30, 35, 40 and 45 mm Standard Lengths : 1 - 140 cm Wall Thickness : 0.05 mm (0.061 mm) Suture Retention : 1.5 N (2.195 N) Burst Strength : 900 mmHg Tensile Strength : 10 N (13.55 N) Water Entry Pressure : 250 mmHg (400)

world class
Medical TEXTILEs
uc to l a n o s r e p e th h it w d elivere d h

References :

1. Walker D et al. Novel structure for a polyester vascular prosthesis with improved mechanical properties. Society for Biomaterials March 1995

3. De Paulis R, et al. A new aortic Dacron conduit for surgical treatment of aortic root pathology. Ital Heart J 2000 1 457-463 4. Wittens C.H.A. et al. European prospective randomised multi-centre axillo-bifemoral trial. Eur J Vasc Surg 1992 6 115-123

2. Goau-Brissonnire O et al. Can knitting structure affect dilatation of polyester bifurcated prostheses? A randomized study with the use of helical computed tomographic scanning. J Vasc Surg 2000 31 157-163

[email protected] www.oem.vascutek.com

VASCUTEK, a TERUMO Company Newmains Avenue, Inchinnan, Renfrewshire PA4 9RR Scotland, UK Tel: (+44) 141 812 5555 Fax: (+44) 141 812 7170 www.vascutek.com
B314/2G