Originally Published Med-Tech Precision Fall 2009
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First Drug-Eluting Stent for Peripheral Arterial Disease Takes on Europe
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Zilver PTX is the world’s first self-expanding drug-eluting stent for the superficial femoral artery. (Photo courtesy of COOK MEDICAL) |
Aging baby boomers and rising obesity and diabetes rates are key contributors to the increasing amount of cases of peripheral arterial disease (PAD). Not only is the disease underdiagnosed, but it’s poised to become a big problem for society as well as a huge clinical issue for literally tens of millions of patients, according to Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division (Bloomington, IN).
According to statistics from recent studies, PAD affects an estimated 27 million people in Europe and North America—including 8–12 million Americans. With these numbers in mind, a new first-to-market drug-eluting stent (DES) is positioned to take advantage of a huge market opportunity in Europe.
Zilver PTX, manufactured by Cook Medical, is the world’s first self-expanding DES for the superficial femoral artery. The device recently received a CE mark following the world’s largest clinical trial (1200 patients) for a peripheral stent. The Zilver stent is currently an investigational device in the United States.
“What’s exciting about Zilver PTX, [is that] now [PAD patients] have a brand new option—a drug-eluting stent,” says Lyles. “It’s a game changer—it puts an option into the mix that’s never been there.” Other treatment options for patients with PAD include balloon angioplasty, bare-metal stenting, and medical therapy that doesn’t involve surgery. According to Lyles, balloon angioplasty has a 30–40% success rate in Europe. After two years, Zilver PTX demonstrated effectiveness in 90–95% of the cases.
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