Contraindications; Available Models - LeMaitre AlboGraft Mode D'emploi

AlboGraft® Polyester Vascular Graft
Instructions for Use – English
Warning: AlboGraft Polyester graft cannot be exposed to temperatures above 45°C (113°F). Please
check temperature sensor immediatlely upon receipt and before use. DO NOT USE THE GRAFT IF
TEMPERATURE SENSOR IS RED.
Description
AlboGraft® Vascular Grafts are made of synthetic material and designed to replace sections of damaged or
malfunctioning arteries. They are made of polyester (polyethylene terephthalate, PET) thread woven into
a seamless tube. In response to a range of surgical indications, AlboGraft Vascular Grafts are offered in two
designs: double velour knitted fabric and double velour woven fabric. The knitted grafts are designed with a
run-proof structure to reduce the risk of fraying or wearing down at their ends. The velour grafts have low-
profile loops on their endoluminal surface to avoid any lumen reduction, and high profile loops on their outer
surface to promote graft anchoring into the surrounding tissues. All AlboGraft grafts are crimped in parallel
rings so that their tubular shape is maintained without kinking.
AlboGraft Vascular Grafts are available with removable external spiral reinforcement (ASC models) made of a
radiopaque biocompatible polypropylene thread, allowing for easy identification of the prosthesis with x-ray.
The external spiral reinforcement is removable, facilitating the creation of anastomoses to the vessel.
Note: AlboGraft Vascular Grafts with Removable External Spiral (ASC Models) are not available for sale in the
United States or Canada.
Guidelines on the outer surface of the graft facilitates orientation during implantation.
The AlboGraft Vascular Grafts impregnated with collagen reduce the permeability to mitigate the problem
of hemorrhaging during implantation so that no preclotting is necessary. The process of impregnation using
bovine collagen maintains both the original structure of the material, and the structural characteristics of the
prosthesis, i.e. flexibility and softness. The collagen is cross-linked by formaldehyde steaming to ensure a bal-
anced reabsorption rate by the host tissues.
Intended Use
AlboGraft Vascular Grafts are intended to be used as a replacement of diseased vessels.
Indications
The AlboGraft Knitted and Woven Vascular Grafts are indicated for use in the replacement or repair of arteries
affected with aneurismal or occlusive disease, such as Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm,
and Peripheral Vascular Disease.
The AlboGraft Vascular Graft (ASC models only) are indicated in extra-anatomic reconstructions and reconstruc-
tions requiring enhanced resistance to kinking and compression, such as axillo-femoral bypass, femorofemoral
crossover and femoro-popliteal bypass.

Contraindications

AlboGraft Vascular Grafts are contraindicated for use in coronary arteries.
AlboGraft Vascular Grafts are contraindicated in patients with known or suspected hypersensitivity to bovine
collagen.
Intended Population
Adults (Male and Female), excluding pregnant women.

Available Models

AlboGraft Vascular Grafts are available in a wide range of models, types and sizes. The graft can be classified
into models according to fabric characteristics, each model being of one or more types (straight " " or bifur-
cated " " ) and sizes (diameter, length). Each graft is identifiable by a model number and a lot/serial number.
The 3-letter code identifies the fabric and presence or absence of collagen (see table below); the lot and serial
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