Regulatory Focus™ > News Articles > Medtronic Renal Denervation Device Accepted for Joint FDA-CMS Review

Medtronic Renal Denervation Device Accepted for Joint FDA-CMS Review

Posted 07 March 2013 | By Alexander Gaffney, RAC

Medical device manufacturer Medtronic has announced that its Symplicity Renal Denervation System has been accepted under a relatively new program that will see the device concurrently reviewed by both the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).


The pilot program, known as Parallel Review, was conceived in October 2011 as a way to allow companies to get their products from an investigational stage to reimbursement more quickly. At present, FDA's approval process and CMS' national coverage determination (NCD) process-the process by which it comes to a decision regarding whether it will pay for a product, generally through Medicare-are usually treated as separate entities, handled by different staff and at different times of the development lifecycle.

"Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming," FDA explained in a statement at the time of the pilot program's launch. "Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations."

The Parallel Review pilot program looks to change this by allowing concurrent review, hypothetically allowing companies to reduce the gap between obtaining FDA approval and a reimbursement decision. Because Medicare is one of the largest purchasers, if not the largest, of medical device products in the US, a positive NCD can sometimes be a de facto approval for a product, as without the NCD a product might not have a market.

"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes. Our goal is to reduce regulatory burden and improve patient outcomes," added Patrick Conway, CMS chief medical officer.

Medtronic Makes Use of Parallel Review

But two years after its launch, the program hasn't seen too many participants, and Medtronic said it was among the first to be accepted by both FDA and CMS to participate in a parallel review.

Its Symplicity Renal Denervation Device is a catheter-based procedure intended to "modulate the output of nerves that lie within the renal artery wall and lead into and out of the kidneys," thereby reducing hypertension by de-activating hyperactive nerves.

Whether or not the system receives regulatory approval from FDA remains to be seen, but Medtronic said its acceptance to the pilot program marked a positive step in getting it to patients more quickly than it could otherwise.

"We are pleased that FDA and CMS have accepted the Symplicity Renal Denervation system for parallel review," Sean Salmon, SVP and president of Medtronic's Coronary and Renal Denervation division, said. "This joint review represents a significant step forward in accelerating patient access to renal denervation in the US. 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 US."

Medtronic said the review of the product at both agencies will be primarily based on data coming from its Symplicity HTN-3 clinical trial, a single-blind, randomized, controlled trial of 530 patients in roughly 90 medical centers across the US.

The trial is expected to conclude in the summer of 2013, with FDA and CMS reviews likely to take place in 2014 or 2015.

Tags: CMS

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