"We are pleased that patients and physicians in Japan have the opportunity to participate in this important drug eluting stent pivotal trial", stated Dr. Shigeru Saito, director of Cardiology and Catheterization Laboratories, Shonan Kamakura Hospital, who enrolled the first patient in Japan and is the principal investigator for the Japan arm of the trial. "We are enthusiastic about the promise of the Xience V for the treatment of coronary artery disease, which impacts more than 2 million lives in Japan each year."
Guidant's Spirit III trial is one of the first 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. HBD represents international collaboration between Japan's Ministry of Health, Labour and Welfare / Pharmaceutical Medical Device Agency, the United States Food and Drug Administration (FDA), industry, clinical investigators, investigational sites and academia. Guidant's participation through piloting Spirit III will provide the opportunity to evaluate Xience V in both Japan and the United States concurrently in the same clinical trial, as opposed to conducting separate sequential trials in each country. The HBD programme may set the stage for earlier introduction of Xience V into Japan.
"We are excited about the enrollment of our first patient in Japan, and pleased with our progress to date with Spirit III", stated John M. Capek, Ph.D., president, Vascular Intervention, Guidant. "In addition to recently passing the halfway mark in enrollment of the United States randomized portion, we have completed enrollment of 240 patients in the United States intravascular ultrasound (IVUS) cohort."
Spirit III is a 1380-patient clinical trial in the United States and Japan. The 1002-patient randomized portion in the United States is a prospective, single-blind trial comparing Xience V versus the Taxus Express 2 paclitaxel eluting coronary stent system for the treatment of coronary artery disease. The Japan arm of the trial is an 88-patient registry; the United States portion includes several registries.
Spirit III United States randomized enrollment has passed the halfway point, with more than 500 patients enrolled. Results of Spirit III are intended to support United States FDA approval of the Xience V Stent System and Ministry of Health and Welfare approval in Japan.
Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. More company news can be found in this VMW issue's article Guidant announces European approval of innovative heart failure lead.