Feature | March 12, 2013

Symplicity Renal Denervation System Participates in FDA Concurrent Review for PMA, Medicare Coverage Determination

FDA-CMS parallel review program designed to enable efficient and earlier patient access to innovative medical advancements

Symplicity Renal Denervation System Medtronic Inc. Parallel Review Program

March 12, 2013 — Medtronic Inc. announced the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have accepted the inclusion of the Symplicity 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 United States. Enrollment in this study is ongoing and expected to be complete by the summer of 2013.

“We are pleased that FDA and CMS have accepted the Symplicity renal denervation system for parallel review. This joint review represents a significant step forward in accelerating patient access to renal denervation in the U.S.,” said Sean Salmon, senior vice president and president, coronary and renal denervation, Medtronic. “We look forward to working with both agencies to ensure an efficient and timely review so that we may offer a new treatment option for the millions of people with treatment-resistant hypertension in the U.S.”

Symplicity HTN-3 is a single-blind, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity renal denervation system in patients with drug-resistant hypertension. The study will randomize 530 patients in up to 90 U.S. medical centers; patients in the clinical trial will be randomized 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 incidence of major adverse events one month following randomization.

Renal denervation therapy is a minimally invasive, catheter-based procedure that modulates the output of nerves that lie within the renal artery wall and lead into and out of the kidneys. The nerves passing to the kidneys are part of the sympathetic nervous system, which affects the major organs that are responsible for regulating blood pressure: the brain, the heart, the kidneys and the blood vessels.

For more information: www.medtronic.com, www.symplifybptrial.com

Related Content

OPTILINK HF trial, ICDs, implantable cardioverter defibrillators, pulmonary congestion, automated alerts, ESC 2015
Feature | Heart Failure| September 01, 2015
Automated alerts for excess fluid accumulation in the lungs did not improve outcomes for heart failure patients with...
News | Atrial Fibrillation| September 01, 2015
The first-ever two-year outcomes from the Global Anticoagulant Registry in the Field - Atrial Fibrillation (GARFIELD-AF...
Pie Medical Imaging, Frost & Sullivan, technology leadership, CAAS, cardiovascular diagnostics

CAAS MRV is part of Pie Medical Imaging's suite of imaging solutions for quantitative cardiovascular diagnosis and treatment planning. - See more at: http://www.itnonline.com/content/pie-medical-imaging-recognized-innovati...

News | Cardiac Imaging| September 01, 2015
Based on its recent analysis of the cardiovascular image management market, Frost & Sullivan recognizes Pie Medical...
Absorb, BVS, bioresorbable stent
News | Stents Bioresorbable| September 01, 2015
September 1, 2015 — A bioresorbable drug-eluting coronary stent showed similar efficacy and safety results compared t
bivalirudin,angiomax
Feature | Antiplatelet and Anticoagulation Therapies| September 01, 2015
September 1, 2015 — Extending treatment with the anticoagulant bivalirudin for at least four hours after completion o
cardiologists, murmurs, identification, study, ACC, heart conditions
News | Cardiac Diagnostics| August 31, 2015
Cardiologists failed to identify more than half of basic and about 35 percent of advanced pre-recorded murmurs,...
Mitralign, Percutaneous Tricuspid Valve Annuloplasty System

Mitralign's Percutaneous Tricuspid Valve Annuloplasty System uses catheter delivered pledgeted sutures that can be cinched together to change the valve annulus geometry to help eliminate valvular regurgitation. 

News | Heart Valve Repair| August 31, 2015
August 31, 2015 — Mitralign Inc. said the U.S.
biomimics, 3D stent
News | Peripheral Arterial Disease (PAD)| August 28, 2015
August 28, 2015 — PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania and second in th
iFR, FFR, Philips, Volcano
News | Cath Lab| August 28, 2015
August 28, 2015 — Philips Healthcare is showcasing its latest cardiology solutions at the European Society of Cardiol
News | Heart Failure| August 28, 2015
August 28, 2015 — BioControl Medical said it has completed enrollment in its INOVATE-HF (INcrease Of VAgal TonE in He
Overlay Init