W.L. Gore & Associates (Flagstaff, Arizona) has received FDA clearance to market its Gore Propaten Vascular Graft for peripheral use — providing an alternative to below-knee surgery for patients with Peripheral Arterial Disease (PAD).

“For the patient it is all about limb salvation, saving your limbs, saving the feet,” Deenu Kanjickal, a product specialist for the Gore Propaten Vascular Graft, told Medical Device Daily. “From an industry perspective, it’s a combination product ... it’s a game-changing technology that we have.”

Kanjickal said the Gore Propaten Vascular Graft is the first ePTFE vascular graft that reduces thrombosis — clotting — and is designed to address the clinical problem of thrombotic vascular graft failure. Gore calls it “the first and only ePTFE-heparin combination in an emerging class of medical products that combine mechanical and biological elements.”

“The exciting news from our perspective is that the Gore Propaten Vascular Graft is the first ePTFE vascular graft,” Kanjickal said. “It’s the first combination product in the graft arena.”

PAD is a blockage of the leg arteries that affects an estimated 8million to 12 million people in the U.S. alone and is associated with heart attack and stroke, according to the American Heart Association (Dallas). PAD is commonly caused by atherosclerosis, a hardening and narrowing of the arteries as a result of plaque build-up in the artery wall, limiting blood flow to the limbs.

Surgical vascular bypass is a common treatment for PAD, Gore said, by using veins from another part of the body to bypass and reroute blood around the closed artery.

What makes the Gore Propaten Vascular Graft unique, Kanjickal said, is that it bonds the anticoagulant drug heparin to the surface of the graft using heparin end-point covalent bonding. The drug also does not come off of the graft, he said. By doing so, the company said it is closing the gap in clinical performance between synthetic and vein grafts.

The Gore Propaten Vascular Grafts has been implanted in more than 10,000 people worldwide since it became available overseas four years ago, the company said.

Kanjickal said the average one-year primary patency for the Gore Propaten Vascular Graft is 80% which compares favorably to the average one-year patencies of 81% for autologous vein grafts and 66% for ePTFE synthetic grafts in the same application.

According to Marc Bosiers, MD, head of the Department of Vascular Surgery at A.Z. St. Blasius Hospital (Dendermonde, Belgium), the use of the heparin-bonded ePTFE graft “... may represent a viable alternative for below-knee bypasses, which have traditionally yielded less than desirable outcomes.” His study, Heparin-bonded expanded polytetrafluoroethylene vascular graft for femoropopliteal and femorocrural bypass grafting: One-year results, appears in this month’s issue of the Journal of Vascular Surgery.

“With the FDA clearance of the Gore Propaten Vascular Graft, Gore expands its portfolio of advanced medical solutions to offer a real alternative for below-knee surgery,” said Robert Thomson, also a product specialist for the Gore Propaten Vascular Graft.

Gore says that products in its medical division have been implanted in 18 million procedures. Its products include vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery.

Earlier this month, Gore said it would no longer be selling products in the plastic surgery market because the company wanted to focus on cardiovascular and general surgery specialties (Medical Device Daily,Nov. 6, 2006).

Other vascular grafts Gore makes includes the Gore-Tex Stretch Vascular Grafts, which the company says does not require preclotting and is designed to resist dilatation and the spread of infection, and the Gore-Tex Intering Vascular Graft which provides easier handling and placement during vascular surgery and is the lowest profile, radically supported graft on the market, the company said (MDD, April 28, 2003).