MINNEAPOLIS--(BUSINESS WIRE)--Dec. 8, 2005--Medtronic, Inc. (NYSE:MDT) announced today that the preliminary results of the Screened Health Assessment and Pacer Evaluation, or SHAPE trial, did not meet the efficacy endpoint of a difference in mean excess weight loss at one year. The SHAPE trial is a U.S. multi-center, double-blind randomized controlled trial of Implantable Gastric Stimulation (IGS) for the management of obesity. This trial was designed to detect the difference in excess weight loss between patients who received IGS therapy and a placebo group who did not. The trial was initiated in May 2004 by Transneuronix, Inc., a privately held medical device company that was acquired by Medtronic in July 2005. Medtronic believes the SHAPE trial was affected by factors including variances in trial execution and unplanned treatment changes.
