FDA approves new 5 mm diameter drug-eluting stent from Cook Medical

Cook Medical announced that a new 5 mm diameter version of Zilver^® PTX^® was approved by the FDA. It is the first 5 mm drug-eluting stent in the U.S. with lengths available up to 140 mm that is indicated to treat vessels as small as 4 mm in diameter. The range of Zilver PTX stent diameters now available will address treatment of vessel sizes from 4-7 mm in diameter. The new diameter is better sized for smaller anatomy than previous sizes of the stent and provides an additional option to treat patients with lesions in their superficial femoral arteries (SFAs).

"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," said Mark Breedlove, vice president of Cook Medical's Vascular division. "We're excited to continue to develop the Zilver PTX line to answer those needs and help more patients around the world."

The new size is the only 5 mm drug-eluting stent on the U.S. market for peripheral artery disease (PAD) and provides another treatment option for lesions in patients with smaller superficial femoral arteries.

Zilver PTX was the U.S.'s first drug-eluting stent used in the treatment of PAD and is the only drug-eluting SFA stent with five-year published data. Zilver PTX has also been shown to cut reinterventions by nearly half through five years, compared to a combination of bare-metal Zilver stents and percutaneous transluminal angioplasty (PTA).

Last year, Cook Medical introduced the 140 mm-length stent in both 6 and 7 mm stent diameters and received expanded indications to treat lesions up to 300 mm per patient. Zilver PTX also received an extended shelf life of two years by the FDA.