First US patient treated following FDA approval of Zilver PTX drug-eluting stent


Just weeks after the FDA approved Cook Medical’s Zilver PTX drug-eluting peripheral stent, Riverside Methodist Hospital in Columbus, USA, has treated the first patient with the device as part of Cook’s US commercial launch.

 “It was a great honour for my institution to be first to implant Cook Medical’s Zilver PTX as part of the stent’s commercial roll-out,” said Gary Ansel, director for the Center for Critical Limb Care at Riverside Methodist Hospital. “This technology is so advanced and offers such prolonged patient benefit, I believe it will very quickly challenge older peripheral arterial disease treatments such as balloon angioplasty and bare metal stenting in the US as the standard of peripheral arterial disease care.”

Zilver PTX, approved for use in the above-the-knee femoropopliteal artery, is the only drug-eluting stent approved for use in a peripheral artery in the USA. The device has a proven drug effect that reduces by more than 50% the need for follow-up procedures to reopen the artery. These followup procedures can be expensive, which places extra burdens on patients, physicians and facilities.

“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,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “Zilver PTX, the only FDA-approved stent that brings the proven benefits of drug elution to the peripheral arteries, is an effective treatment option for patients who suffer with the painful and potentially debilitating consequences of peripheral arterial disease. We are extremely proud to bring this technology to American doctors and the patients they treat.”

This unique combination therapy device combines the mechanical support of stenting with the drug paclitaxel, which limits cell growth that can reclog the artery. The combination has been shown to maintain arterial blood flow to the superficial femoral artery in seven out of ten patients through 24 months after implantation.

Zilver PTX is currently available in 54 markets, including the European Union, Brazil, Australia, Taiwan and Japan.