L. Gore & Associates (Gore) has received CE Mark for the GORE®
Hybrid Vascular Graft. The graft is designed to expand treatment
options for optimal outflow by maximizing the number of access sites
available. Twelve month follow-up data for newly created access implants
demonstrates a trend towards significant improvement in functional graft
patency and reduction in seroma, as compared to historical graft data.
Since commercialization, there have been more than 2500 successful
implants of the GORE Hybrid Vascular Graft in patients suffering
occlusive or aneurysmal diseases, in trauma patients requiring vascular
replacement, for dialysis access, and other vascular procedures.
The GORE Hybrid Vascular Graft, which received FDA clearance in 2010, is
indicated for use as a vascular prosthesis for replacement or bypass of
diseased vessels impacted by aortic aneurysmal, peripheral vascular and
end stage renal disease. The device is designed to address the most
common causes of graft failure; intimal hyperplasia, thrombosis, and
seroma. The device simplifies access to vessels with an optional over
the wire deployment method that reduces vessel injury and dissection.
The GORE Hybrid Vascular Graft has been used to create new access sites
in anatomical locations that would have otherwise been abandoned,
preserving the amount of access sites available throughout the patient's