FDA approves aortic-repair stent grafts

The FDA has granted pre-market approval for two stent grafts, made by Bolton Medical and TriVascular, designed to repair aneurysms in the aorta without resorting to invasive surgery.

Bolton's Relay Thoractic Stent Graft is designed to treat the upper part of the large vessel, inserted into the artery in the groin through a delivery catheter and guided into the chest. TriVascular's Ovation Abdominal Stent Graft, on the other hand, is inserted into the femoral artery and deployed closer to the kidneys.

Both stents are self-expanding, and, once they reach their targets, coat the arterial wall and repair aneurysms and ulcers along the aortic vessel.

TriVascular got a CE mark for its device back in 2010 and has treated more than 1,000 patients around the world since then. Bolton has marketed Relay overseas since 2005, implanting it in about 7,000 patients, the company said.

Both devices will have to compete with similar offerings from Johnson & Johnson's ($JNJ) Codman and W. L. Gore, among others marketing vascular-repair stent grafts. 

- here's the FDA's page on Relay
- read the North Bay Business Journal's story on Ovation

Special Report: TriVascular - Top 10 VC Device deals of H1 2012

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