|Courtesy of Cook Medical|
The privately held Cook Medical may not have the market saturation of the public giants with which it competes, but the company's intense focus on vascular devices paid dividends in November when it snagged FDA approval for Zilver PTX, the U.S.' only drug-eluting stent indicated to treat peripheral artery disease.
The device is a self-expanding stent inserted into the femoral artery and emitting paclitaxel to prevent restenosis while it supports the vessel. In the data Cook served the FDA, Zilver PTX was almost three times as effective as percutaneous transluminal angioplasty and just as safe for patients with PAD in the above-the-knee femoropopliteal artery. Furthermore, patients treated with Cook's device required half as many reintervention procedures as those implanted with bare-metal stents.
For Cook, beating the field to market for PAD is a huge benefit, and the company is toiling through smaller approvals for a range of stent sizes through 2013, planning to commercialize a full stable of Zilver PTX varieties by the end of the year to capitalize on the market.
The device won a CE mark in 2009, and it's available in more than 50 countries around the world. But getting the FDA's blessing opens up a wealth of opportunities for Zilver PTX, and Cook predicts that the approval could revolutionize PAD treatment the way drug-eluting devices did for coronary artery disease.