Abbott Submits Application for Approval of XIENCE™ V Everolimus Eluting Coronary Stent System in Japan
Japan Submission Includes Clinical Data Demonstrating Superiority of XIENCE V Compared to TAXUS® Drug Eluting Stent
Tokyo — Abbott ( NYSE: ABT) today announced that it has submitted an application forSeizo 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 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.”
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, the world’s market-leading bare metal stent. The VISION platform 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.
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 United States. Key results include:
* 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.
“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,” said Shigeru Saito, M.D., F.A.C.C., F.S.C.A.I., F.J.C.C., director, Cardiology and Catheterization Laboratories, Shonan Kamakura GeneralHospital, and principal investigator for the SPIRIT III Japan Registry.
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