FDA Grants Cook Medical Approval for First 5mm Diameter SFA Stent

Cook Medical has won FDA approval for a new version of its drug-eluting stent Zilver PTX having a diameter of 5mm for use in patients having lesions in their superficial femoral arteries (SFAs).

Cardio Vascular Stent

Cardio Vascular Stent

The latest version becomes the first 5mm diameter drug-eluting stent for SFA patients in America, according to the medical device company. It offers a better option for people with anatomy sizes smaller than the existing ones.

The Zilver PTX stent is indicated for the treatment of patients with vessels that are as tiny as 4 mm in diameter. It offers lengths of up to 140 mm. With the new addition, the range now offers options for treatment of vessels with sizes between 4 mm and 7 mm in diameter.

The Zilver PTX range boasts the first drug-eluting stent to become available in the U.S. market for the treatment of peripheral artery disease (PAD), according to Cook Medical. The new size offers the only drug-eluting stent with a 5mm diameter for this condition.

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

Specialty areas under the company’s cardio vascular division include peripheral intervention, aortic intervention and interventional radiology.

The 5mm drug-eluting stent SFA stent is the only one of its kind with five-year published data. In comparison to a combination of percutaneous transluminal angioplasty (PTA) and bare-metal Zilver stents, it was found that the Zilver PTX reduced the need for additional interventions by almost 50 percent through five years.

Cook Medical unveiled the stent having a length of 140mm in 6mm and 7mm diameters in 2017. The company also got approval for expanded indications for treatment of lesions up to 300 mm in length per patient.

The FDA went further to grant the Zilver PTX drug-eluting stent an extended shelf life of two years.

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