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

BioTrace Medical, first U.S. patients, Tempo Temporary Pacing Lead, EP lab, TAVR
News | Leads Implantable Devices| January 13, 2017
BioTrace Medical Inc. announced in December the first commercial use of the company’s Tempo Temporary Pacing Lead since...
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents| January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
Sponsored Content | Videos | Cardiovascular Ultrasound| January 13, 2017
Detailed imaging is needed to support complex interventions for the assessment and procedure guidance.
ACIST-FFR Study, enrollment complete, Navvus catheter, fractional flow reserve
News | FFR Catheters| January 12, 2017
Acist Medical Systems Inc. announced that enrollment is complete for its Fractional Flow Reserve (FFR) Study –...
updated classification system, heart attack risk, Mount Sinai, Johns Hopkins, Journal of the American College of Cardiology, JACC
News | Cardiac Diagnostics| January 12, 2017
Experts at Johns Hopkins and New York's Mount Sinai Health System have published a suggested new plan for a five-stage...
EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD

Gregg W. Stone, M.D., presenting the EXCEL data at TCT 2016 during a standing room only late-breaking trial session.

Feature | Stents| January 12, 2017 | Dave Fornell
The biggest news from the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting this past fall was the results
atrial fibrillation patients, warfarin therapy, medication adherence, University of Michigan study, JAMA Cardiology
News | Antiplatelet and Anticoagulation Therapies| January 11, 2017
For patients with atrial fibrillation, the most common form of heart arrhythmia, a main goal of treatment is stroke...
BioVentrix, Revivent TC Transcatheter Ventricular Enhancement System, LIVE procedure, first in Germany
News | Heart Failure| January 10, 2017
BioVentrix Inc. announced in December the first closed-chest Revivent TC TransCatheter Ventricular Enhancement System...
ischemic heart failure, stem cell therapy, MSCs, CSCs, Minneapolis Heart Institute Foundation, MHIF study
News | Heart Failure| January 10, 2017
Ischemic heart failure from previous heart attacks and coronary artery disease is the leading cause of death in the...
Technology | Vascular Access| January 10, 2017
January 10, 2017 — Teleflex Inc.
Overlay Init