Abbott Submits XIENCE V Application for Approval in Japan
June 2, 2008 - Abbott has submitted an application for Seizo Hanbai Shonin (Marketing Authorization License) to Japan's Ministry of Health, Labour and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) to gain approval for its XIENCE V Everolimus Eluting Coronary Stent System to treat coronary artery disease.
The Shonin application for XIENCE V consisted of safety and efficacy data from the SPIRIT III clinical trial, including data from a Japanese patient population. As previously reported, results from the SPIRIT III U.S. pivotal clinical trial compared XIENCE V to Boston Scientific's TAXUS paclitaxel-eluting coronary stent system in the primary endpoint of in-segment late loss at eight months.
The XIENCE V stent utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is built upon Abbott's MULTI-LINK VISION Coronary Stent System, a bare metal stent. The VISION platform reportedly has a flexible design and facilitates ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery, according to the manufacturer.
Abbott's Shonin submission for XIENCE V included data from SPIRIT III, a large-scale, randomized clinical trial of 1,002 patients conducted in the United States. The submission also included data from two non-randomized registry arms: the SPIRIT III Japan Registry of 88 patients and the SPIRIT III 4.0mm Registry of 69 patients conducted in the U.S.
For more information: www.abbott.com
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