Cook Medical has secured approval from the US Food and Drug Administration (FDA) for the new 5mm diameter version of Zilver PTX superficial femoral artery (SFA) drug-eluting stent.
Zilver PTX, which is claimed to be the first 5mm drug-eluting stent in the US, is available with lengths up to 140mm diameter. It is indicated to treat vessels as small as 4mm in diameter.
The company is Zilver PTX in various stent diameters for the treatment of vessel sizes ranging between 4mm and 7mm.
The new diameter is said to be better sized for smaller anatomy compared to earlier sizes of the stent, enabling to offer an additional option to treat patients with lesions in their SFAs.
The new size is the 5mm drug-eluting stent available in the US market for peripheral artery disease (PAD). It is also the only drug-eluting SFA stent with five-year published data.
According to the company, Zilver PTX demonstrated to reduce reinterventions by nearly half through five years compared against combination of bare-metal Zilver stents and percutaneous transluminal angioplasty (PTA).
In 2017, the firm launched the 140 mm-length stent in both 6mm and 7mm stent diameters and secured approval for expanded indications to treat lesions up to 300mm per patient.
In addition, the FDA granted an extended shelf life of two years for Zilver PTX drug-eluting stent.
Cook Medical vascular division vice president Mark Breedlove said: “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.
“We’re excited to continue to develop the Zilver PTX line to answer those needs and help more patients around the world.”
Cook Medical’s vascular division includes specialty areas of aortic intervention, interventional radiology, lead management and peripheral intervention.
Under aortic intervention segment, the firm provides endovascular treatment solutions for abdominal and thoracic aortic disease.
As part of interventional radiology segment, the company offers image-guided diagnostic and therapeutic devices for percutaneous drainage, centesis, venous access, biopsy, liver access, embolization, and enteral feeding procedures.