Evaluation of the Safety and Performance of Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal Access in Patients with Severe Symptomatic Mitral Regurgitation

Brief description of study

This study is testing an investigational device for mitral regurgitation without the need for open heart surgery. The device is called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. “Investigational” means the device has not been approved by the US Food and Drug Administration (FDA). The purpose of this study is to test a new delivery system to implant the device through the femoral vein and an incision in the lower limb between the knee and the hip.




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