Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent.
Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm.
“We spend a lot of time listening to physicians to understand their clinical needs. Time and time again, they ask for more treatment options for peripheral artery disease,” vascular VP Mark Breedlove said in prepared remarks. “We’re excited to continue to develop the Zilver PTX line to answer those needs and help more patients around the world.”
Initial FDA approval in November 2012 made Zilver PTX the first drug-eluting peripheral stent to hit the U.S. market.
Today Boston Scientific said its Eluvia competitor won approval from the federal safety watchdog, hard on the heels of positive study results revealed at this year’s Transcatheter Cardiovascular Therapeutics conference in San Diego over the weekend.