Medtronic in poor SHAPE
This article was originally published in The Gray Sheet
Executive Summary
Preliminary results of the firm's Screened Health Assessment and Pacer Evaluation trial randomizing patients who received implantable gastric stimulation therapy for the management of obesity against a placebo group failed to meet the efficacy endpoint of a 10 percentage-point difference in mean excess weight loss at one year, the firm announces Dec. 8. Medtronic says it is still committed to the technology and believes the SHAPE trial was influenced by unplanned treatment changes. The trial was initiated in May 2004 by Transneuronix, which Medtronic acquired in July 2005 (1"The Gray Sheet" July 4, 2005, p. 10)...