Cook Medical finally own premarket approval for its Zilver PTX stent, making it the 1st drug-eluting stent approved by the FDA for treatment of peripheral artery disease.
The approval comes 1 year after the FDA’s Circulatory Systems Devices Panel unanimously recommended approval for the device, which is a self-expanding drug-eluting stent coated in paclitaxel.
"This approval marks the start of Cook’s program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries," Cook Medical vice president and peripheral intervention division global manager Rob Lyles said in prepared remarks. "No other company can match Cook’s commitment to this technology, and by the end of 2013, we expect to have a full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters available to U.S. physicians."
The FDA approved the Zilver PTX stent with indication to re-open the femoropopliteal artery when blocked or narrowed as a result of PAD.
"This is a new approach to treating PAD, and Cook Medical is the only manufacturer with a drug-eluting stent that has been shown to inhibit re-narrowing of arteries in the SFA by 50%," a company spokeswoman told MassDevice.com via email today. "This new treatment is going to change the way physicians treat PAD."
PAD occurs when fatty material builds up in arteries, narrowing or possibly blocking blood flow to the head, organs or limbs, the FDA noted. The disease could results leg pain or other serious complications, including skin ulcers or gangrene.
The Zilver PTX, which is comprised of a drug-coated metal mesh stent designed to prop the artery open and prevent recurrent narrowing. The DES provides an alternative for treatment, existing options for which include bare metal stenting, surgical bypass and percutaneous transluminal angioplasty, among other things.
"In order to supply as many physicians as possible with this new technology, Cook is making Zilver PTX available initially in 80 mm lengths in 6 mm and 7 mm diameters," according to a company press release. "The products indications for use also allow 2 Zilver PTX 80 mm stents to be overlapped to treat longer lesions up to 140 mm."
"The FDA approval also includes 40 mm and 60 mm lengths, which will be introduced to the U.S. early in 2013," the company added. "Cook expects to receive regulatory approval for 120 mm length stents in both diameters next year."