Terumo Vascutek ePTFE, Instructions For Use Manual

Page: 4 / 118

4
Description
Vascutek Ltd gelatin sealed ePTFE grafts are manufactured in both supported and unsupported
ePTFE (expanded polytetrafluoroethylene) and sealed with absorbable gelatin on the external
surface only. The gelatin is the same as that used on Vascutek Ltd sealed polyester grafts
1
and has
been shown to hydrolyze within approximately 14 days
2
. The external support, where applicable,
provides kink resistance. The end supported and fully supported grafts are designed to be peeled
to facilitate the fashioning of the anastomoses. The central spiral support is NOT designed to be
removed. Wrapped grafts have an outer layer of ePTFE, which is
NOT
designed to be removed.
All grafts are supplied sterile and will remain so for the stated shelf life, unless the packaging is
opened or damaged.
Origin Of Gelatin
Vascutek Ltd uses gelatin manufactured from animals native to and exclusively raised in Australia.
Australia is one of only a few countries recognised as free from TSE infected animals, including
BSE and scrapie. The EU Scientific Steering Committee has conducted Geographical BSE Risk
Assessment (GBR) and concluded that Australia has the most favourable level 1 rating in relation
to BSE risk.
Indications
Vascutek Ltd gelatin sealed ePTFE grafts are used for systemic vascular repair (excluding Central
Circulatory System as defined by Annex IX, 1.7 of the Medical Device Directive 93/42/EEC) except
for the application of the Blalock-Taussig procedure
3
, examples of which are indicated in the table
below. In Canada, Vascutek Ltd. ePTFE grafts are intended for the creation of subcutaneous
arteriovenous conduits for blood access, bypass or reconstruction of occluded or diseased arterial
blood vessels.
Configuration
Graft Characteristic
Typical Applications
Supported Unsupported
Straight Standard Wall
High Strength &
Compression Resistant
-----------------
Systemic vascular repair, primarily for axillo-
femoral/ bi-femoral bypass and femoral popliteal
reconstruction.
Straight Standard Wall ----------------- High Strength
Systemic vascular repair, primarily for femoral
popliteal reconstruction and the creation of
arteriovenous conduits for blood access.
Straight - Central
Support Standard Wall
High Strength &
Compression Resistant
----------------- Arteriovenous conduit for blood access.
Straight - End Support
Standard Wall
High Strength &
Compression Resistant
----------------- Arteriovenous conduit for blood access.
Straight Thin Wall
Thin, Soft Handle &
Compression Resistant
-----------------
Systemic vascular repair, primarily for femoral
popliteal reconstruction.
Straight Thin Wall -----------------
Thin With Soft
Handle
Systemic vascular repair, primarily for femoral
popliteal reconstruction.
Short Taper ----------------- High Strength
Arteriovenous conduit for blood access. Stepped
taper and short taper configurations minimise the risk
of steal syndrome and high cardiac output
4
.
Short Taper Central
Support
High Strength &
Compression Resistant
-----------------
Arteriovenous conduit for blood access. Stepped
taper and short taper configurations minimise the risk
of steal syndrome and high cardiac output
4
.
English
Instructions for Use
Caution: Federal (USA) law restricts this device to sale,
distribution and use by or on the order of a physician.