Cook Medical has received the regulatory approval from the US Food and Drug Administration (FDA) for its Zilver PTX drug-eluting peripheral stent, designed for treating peripheral arterial disease (PAD) in the superficial femoral artery.
The stent, which is initially available in 80 mm lengths in 6 mm and 7 mm diametres, includes paclitaxel drug which is taken up by the cells of the arterial wall to help prevent the renarrowing of the artery over time.
The company said the stent also expands like a scaffold to help keep the artery open after the catheter is withdrawn.
The FDA approval was based on the randomized, controlled study, which is designed to compare the safety and efficacy of Zilver PTX stent with a bare metal stent.
The study showed that eight out of 10 patients treated with the stent still had open arteries (primary patency) after one year.
The stent, which is approved for sale in the EU, Japan, Brazil and most of South America, Australia, New Zealand and Taiwan, will also be available in 40 mm and 60 mm lengths in the US in early 2013.
In addition, the company is expecting to receive approval for 120 mm length stents in both diameters in the next year.
Cook Medical peripheral intervention division vice president and global leader Rob Lyles said, "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."