August 15, 2012 — Previously unreleased three-year data from the Zilver PTX randomized controlled trial of paclitaxel-eluting stents for femoropopliteal disease indicate that Cook Medical’s paclitaxel-eluting peripheral vascular stent demonstrated 83 percent freedom from 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., principal investigator of the Zilver PTX study, 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 Jan. 24 and is now available in more than 45 countries. It is currently under U.S. Food and Drug Administration (FDA) review and is not available for sale in the United States. Ansel is a paid consultant to Cook Medical with respect to its medical devices.
For more information: www.cookmedical.com