Cook Medical achieved a significant regulatory milestone with FDA approval of its Zilver PTX drug-eluting peripheral stent, marking the first drug-eluting stent approved for peripheral artery use in the United States. OhioHealth Riverside Methodist Hospital in Columbus, Ohio, became the first institution to treat a patient with the device as part of Cook's commercial launch.
Clinical Breakthrough for Peripheral Arterial Disease
The Zilver PTX stent represents a major advancement in treating peripheral arterial disease (PAD), which affects an estimated 8-12 million Americans annually. Dr. Gary Ansel, System Medical Chief for Vascular at OhioHealth, performed the first commercial implantation and expressed confidence in the technology's potential impact.
"This technology is so advanced and offers such prolonged patient benefit, I believe it will very quickly challenge older PAD treatments such as balloon angioplasty and bare metal stenting in the U.S. as the standard of PAD care," said Dr. Ansel.
Device Design and Clinical Performance
The Zilver PTX combines mechanical stenting support with paclitaxel, a drug that limits cell growth responsible for artery re-clogging. This unique combination therapy approach has demonstrated significant clinical benefits in maintaining arterial patency.
Clinical data shows the device maintains arterial blood flow to the superficial femoral artery in seven out of ten patients through 24 months after implantation. The stent's proven drug effect reduces the need for follow-up procedures to reopen the artery by more than 50 percent, addressing a critical clinical challenge in PAD management.
Market Impact and Treatment Landscape
The FDA approval specifically covers use in the above-the-knee femoropopliteal artery, targeting a significant unmet medical need in peripheral vascular intervention. Rob Lyles, vice president and global leader of Cook Medical's Peripheral Intervention division, emphasized the device's potential to transform PAD treatment approaches.
"The first commercial use of this stent represents what I think will be the start of a complete shift in the way physicians will treat PAD patients in this country," Lyles stated.
Disease Burden and Patient Population
PAD represents one of the fastest-growing cardiovascular conditions, characterized by plaque buildup in arteries carrying blood to organs and limbs. While primarily affecting leg arteries, PAD can also impact blood flow to the head, arms, kidneys, and stomach. Patients aged 50 and over with histories of diabetes, smoking, and high blood pressure face elevated PAD risk.
Current treatment modalities include medical management, lifestyle modifications, balloon angioplasty, bare metal stenting, and surgical bypass procedures. The Zilver PTX approval provides physicians with a new therapeutic option that combines proven drug-eluting technology with peripheral vascular intervention.
Global Market Presence
Prior to U.S. approval, the Zilver PTX stent gained regulatory clearance in 54 international markets, including the European Union, Brazil, Australia, Taiwan, and Japan. Thousands of patients worldwide have received treatment with Cook's device, establishing a substantial clinical experience base supporting its safety and efficacy profile.
