Medtronic Commences Postmarket Evaluation of CoreValve Aortic Valve System

March 12, 2010—Medtronic, Inc. (Minneapolis, MN) announced that enrollment has commenced in Europe in the CoreValve Advance postmarket clinical study of the CoreValve transcatheter aortic valve system. CoreValve Advance is a prospective, observational, international study to evaluate clinical outcomes of patients with severe aortic stenosis who are treated with the CoreValve system in standard clinical practice. The CoreValve system received CE Mark approval in March 2007. It is not yet available in the United States for commercial sale or clinical use, the company advised.

Approximately 1,000 patients with severe aortic stenosis will be enrolled in CoreValve Advance at up to 90 clinical trial sites in countries where the device is commercially available. Study patients will be followed for at least 5 years after implantation. The primary endpoint is major adverse cardiac and cerebrovascular events (defined as a composite of all-cause mortality, myocardial infarction, emergent cardiac surgery or percutaneous reintervention, and stroke) at 30 days after the procedure. The study also includes 19 secondary endpoints and data collection related to the health economic impact of CoreValve on patient quality of life and therapy cost effectiveness.

Professor Axel Linke, MD, and Professor Robert Bauernschmitt, MD, are the principal and coprincipal investigators for the CoreValve Advance study. Professor Horst Sievert, MD, performed the first study procedures.

"We have been very pleased with past clinical results using the CoreValve system, and we anticipate great scientific value for future patients by participating in the CoreValve Advance study," commented Professor Sievert. "The resulting data will provide important information to physicians and regulatory officials worldwide related to broadscale safety and device performance for patients with severe aortic stenosis who often are at high risk for open heart surgery."