Cook Medical announced the launch of what it said is Canada's first drug-coated stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery on June 5 at the Interventional Radiology Association meeting in Montreal.
"Launching Zilver PTX in Canada brings the benefits of drug-eluting stents to Canadian PAD patients," said Mark Breedlove, vice president of Cook Medical's Peripheral Intervention clinical division, in a statement. "We're very pleased to be the company that introduces this technology in Canada."
It will be sold in lengths ranging from 40 mm to 100 mm and diameters of 6 mm or 7 mm.
Self-expanding Zilver PTX is coated with paclitaxel, a drug that inhibits the growth of scar tissue in the artery. Paclitaxel remains in the vessel wall for as long as 56 days, according to the product's website. The drug discourages excess mitosis following surgery by binding to microtubules, a constituent of the internal scaffolding used in cell division. Paclitaxel is also delivered to cancer patients in chemotherapy.
In a postmarket study of 907 Japanese patients with PAD, 91.4% of the Zilver PTX patients at the 12-month follow-up did not need a repeat percutaneous intervention of the target lesion, the company said in a May 29 statement.
Cook says the product has been used to treat more than 25,000 PAD patients across the world. Zilver PTX was launched in Europe in 2009 and the U.S. and Japan in 2012. The stent was temporarily recalled in 2013, during which time shipments of the product ceased for a few months.
Qmed estimated that Zilver PTX was on track for annual revenues of $110 million solely in the U.S. prior to the recall.
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