Japanese MHLW approves Abbott's XIENCE V Everolimus Eluting Coronary Stent System

Abbott (NYSE: ABT) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V® Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Japan is the second largest drug eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year. The company plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization.

"With today's approval, physicians in Japan will now have access to a next-generation drug eluting stent that offers outstanding ease of use and excellent clinical performance and safety. XIENCE V is the ideal combination as documented by the more than 16,000 patients who have been enrolled in the SPIRIT family of trials," said Robert Hance, senior vice president, vascular, Abbott. "Each aspect of XIENCE V's design, from the thin struts to the flexible delivery system to the drug and polymer, was carefully engineered for optimal deliverability and to improve safety and efficacy outcomes for patients compared to earlier generation stents. These attributes have made XIENCE V the market-leading drug eluting stent around the world, and we look forward to making XIENCE V available to physicians in Japan shortly."

"XIENCE V is flexible and easy to deliver through the coronary anatomy to the lesion site. These attributes combined with the strength of the safety and efficacy data supporting it give me confidence that XIENCE V is a true next-generation stent that has the potential to benefit heart patients in Japan," 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 General Hospital, and principal investigator for the SPIRIT III Japan Registry.

The outstanding data for XIENCE V includes clinically superior long-term efficacy and safety results in the primary endpoints of the pivotal trials, and among the SPIRIT family of trials. The SPIRIT III Japan Registry of 88 patients demonstrated similar angiographic and clinical results to the outstanding outcomes from the SPIRIT III U.S. trial. In the SPIRIT III Japan Registry, XIENCE V demonstrated a single-digit rate of major adverse cardiac events (MACE, 8.0 percent), and no cases of stent thrombosis (blood clots) out to one year. MACE is an important composite clinical measure of safety and efficacy outcomes for patients and is defined as cardiac death, heart attack (all myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR).

In the SPIRIT III U.S. trial, XIENCE V demonstrated an impressive low rate of very late stent thrombosis with no additional events between two and three years, and a 43 percent reduction in the risk of MACE compared to the TAXUS® Express(2) Paclitaxel-Eluting Coronary Stent System (TAXUS) at three years (9.1 percent for XIENCE V vs. 15.7 percent for TAXUS,>

In SPIRIT IV, one of the largest randomized trials comparing two drug eluting stents, XIENCE V demonstrated a statistically significant 39 percent reduction in target lesion failure (TLF) compared to TAXUS at one year (3.9 percent for XIENCE V vs. 6.6 percent for TAXUS,>

Additionally, in the investigator-initiated COMPARE trial of real-world patients, XIENCE V demonstrated significantly better outcomes in key safety and efficacy measures compared to the TAXUS® Liberte Paclitaxel-Eluting Coronary Stent System (TAXUS). At one year, XIENCE V demonstrated a statistically significant 31 percent reduction in MACE compared to TAXUS (6.2 percent XIENCE V vs. 9.1 percent TAXUS,>