FDA Approval Means Zilver® PTX® Is First Drug-Eluting PAD Stent In U.S.

Peripheral vascular disease treatments have shuffled under the spotlight in recent months with a seemingly endless trail of new devices and approvals for unblocking diseased vasculature. Now Cook Medical can say it has the first drug-eluting stent to be FDA approved for the job.

In short

Cook Medical has received U.S. FDA approval for the first devices in its Zilver® PTX® Drug-Eluting Peripheral Stent portfolio, company officials reported today. It’s the first time the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery.

Background

Cook’s Zilver PTX stent, coated with paclitaxel, is intended to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA). It is already approved for sale in more than 50 markets, including the European Union, Japan, Brazil and most of South America, Australia, New Zealand and Taiwan. Following FDA approval it is being introduced to the U.S. market in a five-step process which Cook says is designed to make this technology available to as many patients as possible initially.

The plan is to make Zilver PTX available initially in 80 mm lengths in 6 mm and 7 mm diameters. The products indications for use also allow two Zilver PTX 80 mm stents to be overlapped to treat longer lesions up to 140 mm. The FDA approval also includes 40 mm and 60 mm lengths, which will be introduced to the U.S. early in 2013.
Cook expects to receive regulatory approval for 120 mm length stents in both diameters next year.

In its pivotal clinical study, eight out of ten patients treated with Zilver PTX still demonstrated primary patency after one year compared to only 3 out of 10 patients treated with angioplasty alone. Further to that, patients who received a bare metal stent, the current comparator, required more than twice as many reintervention procedures to reopen the SFA as patients who received Zilver PTX.

Physician comments

“After conducting the largest randomised controlled study of peripheral stenting ever undertaken, we now see remarkable results in patients treated with Zilver PTX,” said Michael Dake, M.D., a professor in the Department of Cardiothoracic Surgery at Stanford University School of Medicine and medical director of the Cath/Angio Laboratories at Stanford Medical Center, Palo Alto, Calif.

 “With this approval, treating PAD in the U.S. will begin to undergo the same revolution that drug elution did for treating coronary artery disease,” added Gary Ansel, M.D., director for the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, Ohio, and an assistant clinical professor of medicine in the Department of Internal Medicine at the University of Toledo Medical Center in Toledo, Ohio. “Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for PAD patients worldwide.”

Company comments 

“This approval marks the start of Cook’s program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “No other company can match Cook’s commitment to this technology, and by the end of 2013, we expect to have a full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters available to U.S. physicians.”

Note: Drs. Dake and Ansel, who served as global principal investigators for the Zilver PTX clinical trial, are paid consultants to Cook Medical with respect to its medical devices.)

Source: Cook Medical

published: November 16, 2012 in: Approval/Clearance, Cook, Vascular

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