Milestone Marks a Critical Step Forward in Bringing Renal Denervation to Patients in the U.S.

MINNEAPOLIS - Medtronic, Inc., today announced it has finished randomizing Symplicity HTN-3, the company's pivotal U.S. clinical trial of the Symplicity(TM) renal denervation system for treatment-resistant hypertension. Renal denervation is a minimally invasive, catheter-based procedure to reduce activity of the renal (kidney) nerves, which are part of the sympathetic nervous system and help regulate blood pressure. The Symplicity renal denervation system is available in more than 70 countries worldwide; it is only available for investigational use in the U.S. and Japan.

The Symplicity renal denervation system is also one of the first medical devices to participate in the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) parallel review program, which will allow the CMS to begin national coverage determination while the FDA completes its review of safety and efficacy. Data from the Symplicity HTN-3 clinical trial will be a significant component of the parallel review.

"Paralleling the increased prevalence of obesity, treatment-resistant hypertension has emerged as a major health problem in the Western world. The results of this study will provide the medical community with data that will not only further our understanding of the impact of renal denervation on treatment-resistant hypertension, but also potentially help bring a new treatment option to people in the U.S. affected by this condition," said George Bakris, M.D., professor of medicine and director of the ASH Comprehensive Hypertension Center at the University of Chicago Medicine and past-president of the American Society of Hypertension, and co-principal investigator of Symplicity HTN-3.

Symplicity HTN-3 is Medtronic's first blinded, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity renal denervation system in patients with treatment-resistant hypertension in the U.S. The trial randomized 530 patients across nearly 90 medical centers in the U.S. to receive either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications alone. The primary endpoints of the study are the change in blood pressure from baseline to six months following randomization and the incidence of major adverse events one month following randomization and renal artery stenosis to six months.

"Because patients had to meet the most strict inclusion criteria of any renal denervation clinical trial to date, enrollment in Symplicity HTN-3 was at first challenging," said Deepak L. Bhatt M.D., M.P.H., chief of cardiology, VA Boston Healthcare System, director, Integrated Interventional Cardiovascular Program, Brigham and Women's Hospital and VA Boston Healthcare System, professor of medicine, Harvard Medical School, and co-principal investigator of Symplicity HTN-3. "The Symplicity HTN-3 study investigators and research coordinators should be recognized for their leadership in addressing initial recruiting challenges to complete this seminal clinical trial."

Source: Medtronic, Inc.