Cook's Zenith endograft for endovascular repair of abdominal aortic aneurysms (AAA) has been approved for sale in Japan. The decision means the Zenith endovascular graft system is the first and only device available for endovascular repair of AAA in Japan.
Cook's Shonin filing (regulatory approval) was granted in July 2006 by the Japanese Ministry of Health, Labor, and Welfare. The Zenith endograft is approved as a new medical device and that status will be re-examined three years after the approval date. The company will also provide detailed clinical training to Japanese physicians to ensure their safe and effective use of the device. This Shonin was granted on the basis of the Zenith US pivotal trial results, as well as on the basis of the limited confirmation trial that was performed in Japan. The device will be distributed in Japan by Medico's Hirata, Inc.
The major benefits of the Zenith design for endovascular AAA repair include suprarenal fixation with anchoring barbs to ensure maximal stability and graft-to-vessel sealing, woven polyester graft material that is lightweight, strong and shrink-resistant, and the H&L-B One-Shot Introducer System that allows simple, accurate deployment and positioning of the graft.
Professor Takao Ohki, at Jikei University School of Medicine, Department of Vascular Surgery, said, "The first approval of an endograft marks the beginning of a new era in endovascular therapy in Japan. There are many patients in Japan waiting for an endograft to become available. The operating time for this procedure can be as little as 80 minutes when performed under local anaesthetic. We are very excited to see this technology become available in Japan and look forward to successfully treating many patients in Japan, as has been the experience elsewhere in the world."
Japanese approval of the Gore Excluder (WL Gore & Associates) and the Endologix PowerLink (Endologix) is expected in late 2006.
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