Orthopedics In Brief
This article was originally published in The Gray Sheet
Executive Summary
Medtronic set to begin spinal stabilization trial: Firm is enrolling patients for the first of three clinical trials evaluating the use of its Diam spinal stabilization system. Medtronic announced IDE clearance to begin studies of the nonfusion spinal stabilization system on July 10. Diam relieves spine pressure by rerouting spinal load, similar to St. Francis Medical's X-Stop device, PMA approved in 2005. Medtronic's initial study, slated to begin in August, will examine the safety and effectiveness of the Diam system in patients with degenerative stenosis. The second trial, to begin in Europe in September, will compare discectomy with Diam to discectomy alone. A third study will evaluate Diam's use in degenerative disc disease. Medtronic expects to enroll a total of 430 patients in up to 25 centers in the U.S. and Europe...