Medtronic Says Symplicity Renal Denervation System Accepted to Participate in Concurrent Review for Joint FDA Premarket Approval, National Coverage

Medtronic, Inc.

today announced the U.S. Food and Drug Administration (FDA)and the Centers for Medicare & Medicaid Services (CMS) have accepted the inclusion of the Symplicity(TM) renal denervation system for treatment-resistant hypertension in their parallel review program, which will allow CMS to begin consideration for national coverage determination while the FDA completes its review of safety and efficacy. The Symplicity renal denervation system currently is only available for investigational use in the United States. The Symplicity renal denervation system is one of the first medical devices to participate in the pilot program for concurrent review designed to facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies. The two federal agencies accepted the Symplicity renal denervation system into the parallel review pilot program through a selection process that is limited to a few innovative devices per year. The parallel review will be based primarily on results from Symplicity HTN-3, Medtronic's U.S. clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension. In August 2011, the FDA approved Symplicity HTN-3, allowing Medtronic to become the first company to conduct a randomized, controlled trial of renal denervation in the U.S.  Enrollment in this study is ongoing expected to be complete by the summer of 2013.