June 2, 2008 -- Although Abbott's (NYSE: ABT) XIENCE V™ Everolimus Eluting Coronary Stent System is still awaiting U.S. FDA approval, the company already has submitted its application for Seizo Hanbai Shonin (Marketing Authorization License) to Japan's Ministry of Health, Labour and Welfare (MHLW)/ Pharmaceuticals and Medical Devices Agency (PMDA). The Japanese market is estimated at 200,000 stents implanted annually, the largest outside of the United States.

Abbott was one of the first companies to participate in Harmonization By Doing (HBD), an initiative to promote the convergence of regulatory requirements, processes and timelines between Japan and the United States, which allowed the XIENCE V stent to be evaluated in both countries concurrently in the same clinical trial as opposed to conducting separate sequential trials in each country. By comparison, Boston Scientific waited three years after U.S. approval for its Taxus drug-eluting stent to be launched in Japan.

Shigeru Saito, M.D.

Dr. Shigeru Saito, MD, FACC, FSCAI, FJCC and principal investigator for the SPIRIT III Japan Registry, stated: "The strong, positive data indicate that XIENCE V is a true next-generation drug eluting stent that combines advanced technology with outstanding clinical benefits in the treatment of coronary artery disease." Dr. Saito is director, Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, and is known worldwide for his work in stents, chronic total occlusions (CTO) and his advocacy of the transradial approach to catheter-based procedures.

More information follows from Abbott's news release.

The company stated that 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® 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."

• Statistical superiority for XIENCE V compared to TAXUS in the primary endpoint of in-segment late loss at eight months in the randomized clinical trial, where XIENCE V demonstrated a statistically significant 50 percent reduction in late loss compared to TAXUS (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). In-segment late loss is a measure of vessel re-narrowing.
• Statistical non-inferiority for XIENCE V compared to TAXUS in the co-primary endpoint of target vessel failure (TVF) at nine months in the randomized clinical trial, where XIENCE V demonstrated an observed 20 percent reduction in TVF compared to TAXUS (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, heart attack (myocardial infarction or MI) or target vessel revascularization (TVR).
• An observed 43 percent reduction in major adverse cardiac events (MACE) at nine months (4.6 percent for XIENCE V vs. 8.1 percent for TAXUS) with XIENCE V compared to TAXUS in the randomized clinical trial. MACE is an important clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).
• Positive results confirming the efficacy and safety of XIENCE V from the SPIRIT III Japan Registry. The Japan Registry met its primary endpoint of in-segment late loss at eight months. A full analysis of the SPIRIT III Japan Registry will be presented later this year.

Everolimus is licensed to Abbott by Novartis for use on its drug eluting stents.

About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.

About Abbott
Abbott ( NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Source: Abbott Vascular with additional reporting by Burt Cohen of Angioplasty.Org

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