Medtronic's Symplicity Renal Denervation System Included in FDA-CMS Parallel Review Pilot Program

March 6, 2013—Medtronic, Inc. (Minneapolis, MN) announced that the company's Symplicity renal denervation system for treatment-resistant hypertension has been accepted into the parallel review program of the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). The FDA-CMS program will allow CMS to begin consideration for national coverage determination for the device while the FDA completes its review of safety and efficacy.

According to Medtronic, 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 pilot program for concurrent review is designed to facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies.

Medtronic advised that the parallel review will be based primarily on results from the Symplicity HTN-3 clinical trial, which was approved by the FDA in August 2011. Enrollment in this study is ongoing and expected to be complete by the summer of 2013.

As summarized in the company's press release, Symplicity HTN-3 is a single-blind, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity system in patients with drug-resistant hypertension. The study will randomize 530 patients in up to 90 medical centers in the United States. Patients will be randomized to receive either renal denervation and treatment with antihypertensive medications or treatment with antihypertensive medications alone. The primary endpoints of the study are the change in blood pressure from baseline to 6 months after randomization and incidence of major adverse events at 1 month after randomization.

In April 2010, the Symplicity renal denervation system was launched commercially and is available in parts of Europe, Asia, Africa, Australia, Canada and Latin America. In the United States, it is currently only available for investigational use, advised Medtronic.