Cook Medical Receives FDA Approval for First 5 mm-Diameter SFA Drug-Eluting Stent

Cook Medical announced that a new 5 mm diameter version of Zilver PTX was approved by the U.S. Food and Drug Administration (FDA). It is the first 5 mm drug-eluting stent in the United States with lengths available up to 140 mm 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 mm–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 PTX¹ was the United States’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).²
 
Last year, Cook Medical introduced the 140 mm-length stent in both 6 mm 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.

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today the company combines medical devices, biologic materials, and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently.

References
1. Caution: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Use of this drug-eluting peripheral stent carries the risks associated with peripheral artery stenting, including vascular complications and/or bleeding events. Refer to the Instructions for Use (IFU) for full prescribing information including information on potential adverse events, contraindications, warnings, precautions, and summary of clinical data.
2. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX. Circulation. 2016;133:1472-1483.