Cook Medical received FDA marketing approval for the first devices in its Zilver PTX Drug-Eluting Peripheral Stent portfolio, company officials reported on 15 November 2012. It is the first time the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery.
“This approval marks the start of Cook’s programme to bring the benefits of drug elution to US physicians treating the peripheral arteries,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “The approval of Zilver PTX also dramatically improves the prospects for patient care amongst the 8-12 million Americans diagnosed annually with peripheral arterial disease. As American doctors see the kind of results their European counterparts have been experiencing using Zilver PTX for the last three years, we expect a strong increase in the number of stenting procedures. To meet that demand, we will make our entire suite of drug-eluting stents available to U.S. physicians in the most commonly used diameters and lengths in the coming months. And since Cook is the only US company with a drug-eluting stent indicated for treating peripheral arterial disease, we see a tremendous business opportunity for our company in the 160,000 superficial femoral artery stent procedures done here annually.”
The Zilver PTX Drug-Eluting Stent is intended to treat peripheral arterial disease in the superficial femoral artery.
In order to supply as many physicians as possible with this new technology, Cook is making Zilver PTX available initially in 80mm lengths in 6mm and 7mm diameters. The products indications for use also allow two Zilver PTX 80mm stents to be overlapped to treat longer lesions up to 140mm. The FDA approval also includes 40mm and 60mm lengths, which will be introduced to the USA early in 2013. Cook expects to receive regulatory approval for 120mm length stents in both diameters next year.
Data from Cook’s pivotal clinical trial indicate:
- Eight out of 10 patients treated with Zilver PTX still had open arteries (primary patency) after one year. That compares to only three out of 10 patients treated with angioplasty alone.
- Patients who received a bare metal stent required more than twice as many re-intervention procedures to reopen the superficial femoral artery as patients who received Zilver PTX.
“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, 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, USA.
“With this approval, treating peripheral arterial disease in the USA will begin to undergo the same revolution that drug elution did for treating coronary artery disease,” added Gary Ansel, director for the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, USA, and an assistant clinical professor of medicine in the Department of Internal Medicine at the University of Toledo Medical Center in Toledo, USA. “Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for peripheral arterial disease patients worldwide.”
Cook’s Zilver PTX stent 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. The device is being introduced to the US market in a five-step process designed to make this technology available to as many patients as possible initially.