Cook has announced on its website that previously unreleased three-year data from the Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease indicate that it’s paclitaxel-eluting peripheral vascular stent demonstrated 83.0 percent freedom from Target Lesion Revascularisation(TLR) at 36 months in the PTX group, compared to 70.2 percent for patients treated with optimal percutaneous transluminal angioplasty and bare metal stents in the 479 patient study.
Gary M. Ansel, M.D., Zilver PTX study principal investigator, presented the study findings at the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) meeting last month in Niigata, Japan.
The device is currently available for sale in Japan after approval from the Pharmaceuticals and Medical Devices Agency on January 24 and is now available in more than 45 countries. It is currently under U.S. Food and Drug Administration review and is not available for sale in the United States. Dr. Ansel is a paid consultant to Cook Medical with respect to its medical devices.
Source: Cook Medical