Cook Medical has just announced that the FDA Circulatory System Devices Panel of Medical Devices Advisory Committee unanimously voted to recommend approval of the Zilver PTX drug eluting stent based on safety, efficacy and acceptable risk profile for the treatment of peripheral artery disease in the superficial femoral artery. The company hopes this will help ultimately lead to FDA approval to sell the device in the US. The device already received CE Mark approval in Europe in 2009. According to Cook Medical’s website, the 1-year fracture rate was just 0.9% and it demonstrated 50% reduced restenosis rate at 2-years when compared to bare-metal stenting.
Peripheral artery disease is the result of atherosclerotic plaque buildup in the arteries supplying blood to the legs. Significant stenosis of these arteries can lead to symptoms including leg cramping, ulcers or sores in the feet, difficulty in walking, and possibly gangrene requiring amputation.
Press release: Cook Medical’s Zilver® PTX® Drug-Eluting Stent Technology Receives Unanimous Recommendation from FDA Advisory Committee …
Product page: Zilver PTX …