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Abbot Submits Xience V Eluting Stent for Approval in Japan

Biotech Equipment Update 2008, July 1, 16, 7

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Description

Abbott (NYSE:ABT) 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(TM) 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 demonstrated the superiority of XIENCE V over Boston Scientific's TAXUS(R) paclitaxel-eluting coronary stent system in the primary endpoint of in-segment late loss at eight months. "Results of the SPIRIT III Japan Registry were very similar with those of the U.S. randomized clinical trial, which was the first head-to-head clinical trial to demonstrate the superiority of one drug eluting stent over another drug eluting stent," said Daniel Estay, divisional vice president, Abbott Vascular Asia Pacific and Japan. "XIENCE V represents an advancement in drug eluting stent science and reinforces Abbott's deep commitment to providing physicians and patients in Japan with leading technologies and products in cardiac and vascular care."

Abbot Submits Xience V Eluting Stent for Approval in Japan
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  • $5.99
  • Available on iPhone, iPad, iPod touch, and Mac.
  • Category: Industries & Professions
  • Published: Jul 01, 2008
  • Publisher: Worldwide Videotex
  • Seller: The Gale Group, Inc.
  • Print Length: 5 Pages
  • Language: English
  • Requirements: To view this book, you must have an iOS device with iBooks 1.3.1 or later and iOS 4.3.3 or later, or a Mac with iBooks 1.0 or later and OS X 10.9 or later.

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