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

Cardioband, valtech, Edwards Lifesciences, transcatheter mitral repair, transcatheter tricuspid valve repair, transcatheter annuloplasty

An illustration of how the transcatheter Cardioband System can used as a non-surgical form on annuloplasty repair. 

News | Heart Valve Technology| December 02, 2016
December 2, 2016 — Edwards Lifesciences Corp.
coronary CT angiography, CCTA, alcohol consumption, CAD, coronary artery disease, RSNA 2016
News | CT Angiography (CTA)| November 29, 2016
Researchers using coronary computed tomography angiography (CCTA) found no association between light to moderate...
Sponsored Content | Videos | Robotic Systems| November 22, 2016
Corindus Vascular Robotics received U.S.
Infinix-i Sky +, RSNA 2016, Toshiba, angiography systems

Toshiba Medical’s Infinix-i product line, including the Infinix-i Sky +, delivers patient access, image quality and safety features for virtually any image-guided procedure, including those in hybrid OR settings.

News | Angiography| November 21, 2016
November 21, 2016 – Healthcare providers seeking versatile imaging technology for their angiography needs can find a
News | Cath Lab| November 21, 2016
November 21, 2016 – A single-center study sponsored by the National Institutes of Health (NHLBI) failed to show an ea
InspireMD, CGuard embolic protection system, EPS, clinical data, internal carotid artery stenosis, ICA
News | Stents Carotid| November 18, 2016
November 18, 2016 — InspireMD Inc.
Mitralign, Trialign System, tricuspid regurgitation, first transcatheter repair, cardiac implantable device lead, Piedmont
News | Heart Valve Technology| November 18, 2016
Mitralign Inc. announced the successful compassionate use treatment of a patient suffering from tricuspid regurgitation...
Boston Scientific, HeartLogic Heart Failure Diagnostic Service, MultiSENSE trial data, AHA Scientific Sessions 2016
News | Heart Failure| November 18, 2016
Boston Scientific recently announced results from the first clinical trial evaluating the performance of the HeartLogic...
Sponsored Content | Videos | TCT| November 18, 2016
DAIC Editor Dave Fornell takes a video tour of some of the most innovative new interventional cardiology technologies
Sponsored Content | Videos | Heart Valve Technology| November 18, 2016
A discussion with Juan Granada, M.D., about transcatheter mitral valve advancements and device challenges at the Tran
Overlay Init