W.L. Gore & Associates touted CE Mark approval in the European Union for its Gore Hybrid Vascular Graft.
The device, which won FDA clearance in 2010, is indicated for use as replacement or bypass of diseased blood vessels while addressing common causes of graft failure.
The graft is a vascular prosthesis designed to expand treatment options for blood outflow by working in the maximum number of sites available.
"The Gore Hybrid Vascular Graft, for the 1st time, palpably bridges the gap between traditional vascular and endovascular surgery," spokesperson Dr. Jean Bismuth, of the Methodist DeBakey Heart & Vascular Center in Houston, said in prepared remarks. "It is the first significant innovation in vascular grafts in years, providing tremendous versatility."
The device has proven successful in AV access, aortic debranching and arterial bypass, according to the company.
"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 long-term therapy," according to a press release.
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