Cook Medical receives FDA approval for first 5mm diameter SFA drug-eluting stent

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Cook Medical have announced that a new 5mm diameter version of Zilver PTX was approved by the US Food and Drug Administration (FDA). It is the first 5mm drug-eluting stent in the USA with lengths available up to 140mm that is indicated to treat vessels as small as 4mm in diameter. The range of Zilver PTX stent diameters now available will address treatment of vessel sizes from 4–7mm 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 5mm drug-eluting stent on the US market for peripheral artery disease (PAD) and provides another treatment option for lesions in patients with smaller superficial femoral arteries.

Zilver PTX1 was the USA’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 re-interventions 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 140mm-length stent in both six and 7mm stent diameters and received expanded indications to treat lesions up to 300mm per patient. Zilver PTX also received an extended shelf life of two years by the FDA.

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