Cath Lab Digest

Cook Medical announced that the company’s Zilver PTX drug-eluting stent for treating peripheral artery disease in the superficial femoral artery (SFA) has received a positive recommendation from the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee. The panel members voted unanimously to recommend approval of the device on the basis of its safety, efficacy, and acceptable risk profile. This important achievement will ultimately lead to FDA approval to commercialize the Zilver PTX stent in the United States, according to Cook Medical.

The Zilver PTX is a self-expanding nitinol stent that is coated with the cytotoxic drug, paclitaxel, without any polymer or binder. The device comes in diameters of 5 to 10 mm and lengths of 20 to 80 mm and is preloaded onto 6 and 7 Fr delivery systems. According to the FDA, the proposed indications for use of the Zilver PTX stent are treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries that have reference vessel diameters ranging from 4 to 9 mm and total lesion lengths up to 280 mm. The device received CE Mark European approval in 2009 and is currently available in 48 countries around the world.

While the trial results presented and published so far are indeed impressive, the 1-year outcomes for the SFA are only marginally better that those achieved with the LifeStent bare metal device (C.R. Bard) during the Resilient trial. The very small gain with Zilver PTX comes at a price premium… but it may still be a little too early for a final judgment on this. Stay tuned…