Zilver Drug Coated Leg Stent for Treating PAD From Cook Medical Meets Safety Goals
Posted Oct 12 2011 1:38am
A while back I spoke with Rob Lyles from Cook Medical when they stent came out and being it goes in your leg as treatment for PAD, it’s has some different areas it needs to address, one being stability. When you think about your heart its there in one place, but legs move and do all kinds of activities and thus the placement and stability mean lot as you don’t want it to move.
The stent has been approved in Europe already. In addition another article of interest was an interview I did a while back with UCLA Dr. Peter F. Lawrence, Director of the UCLA Gonda Vascular Center who treats patients for PAD. BD
Oct. 11 (Bloomberg) -- A drug-coated stent from Cook Medical met safety and effectiveness goals in the treatment of blocked femoral arteries, according to a staff report by U.S. regulators weighing whether to clear the device for sale.
Clinical trials showed closely held Cook’s stent, the Zilver PTX, worked as well as or better than angioplasty and non-medicated stents in unclogging vessels, Food and Drug Administration staff said in a preliminary review released today on the agency’s website. Outside advisers to the FDA will meet Oct. 13 to evaluate the findings.
The device from Bloomington, Indiana-based Cook would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg. The stent could reduce leg amputations and painful bypass surgeries, the company said after winning approval for the device in Europe two years ago.