FDAnews
www.fdanews.com/articles/149032-medtronic-completes-high-risk-patient-enrollment-in-corevalver-u-s-pivotal-trial-and-gains-fda-approval-to-study-intermediate-risk-patients-in-global-surtavi-trial

Medtronic Completes High-Risk Patient Enrollment in CoreValveR U.S. Pivotal Trial and Gains FDA Approval to Study Intermediate-Risk Patients in Global SURTAVI Trial

August 29, 2012
Medtronic has reached two clinical program milestones for its CoreValve System in the United States. First, it completed enrollment in its study of high risk patients in its CoreValve U.S. Pivotal Trial, which concludes the total trial enrollment of more than 1,500 patients with severe aortic stenosis who are at high or extreme risk for aortic valve surgery.
Reuters