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New Device From Cook Awaits Final Approval From FDA

By Alex Roy

Posted October 14, 2011



A Food and Drug Administration panel unanimously voted Thursday to support approval of the new femoral artery stent.



The stent, known as Zilver PTX, is the first of its kind to treat peripheral artery disease in the femoral artery, which is in the thigh. The product is currently available in 48 countries, but has not been approved by the FDA for use in the US.

Indiana University Cardiologist Jeffrey Breall says the old treatment involved inflating a balloon in the artery to unclog plaque buildup. Often, this procedure would fail and the artery could collapse. A stent is a metal support that helps the balloon hold the artery open.

Cook's new stent improves on the design. It is coated with a drug that inhibits cell growth, which Breall says can further reduce the risk of artery collapse.

"Stents themselves in the periphery have issues because the fracture and they crack," he says. "However, this new drug-coated stent really looks like it's really going to impact that, so I think a lot more people are going to be using stents, specifically drug-coated stents, in the periphery."

The FDA advisory committee was comprised of 11 doctors who rigorously examined the product for effectiveness and safety.

Cook Medical Peripheral Intervention division vice president Rob Lyles, says the company submitted a 34 thousand page report to the committee.

"So as you can imagine, it's sort of like preparing for the ultimate final exam. It's a very intensive process," Lyles says.

The committee approval is just one step towards releasing Zilver PTX. It still must be approved by the FDA before going on sale in the US. Lyles says he hopes Zilver PTX will hit the market in the US sometime next year.

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