Regulatory Focus™ > News Articles > How the Failure of Medtronic's Symplicity Device Spells Trouble for FDA

How the Failure of Medtronic's Symplicity Device Spells Trouble for FDA

Posted 09 January 2014 | By Alexander Gaffney, RAC

One of the US Food and Drug Administration's (FDA) marquee pilot programs may now be in jeopardy through no fault of its own after the apparent failure of the flagship device that was meant to test the capabilities of the program.

The Program

The program in question is known as Parallel Review, and was created 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 the Center for Medicare and Medicaid Services' (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 by FDA and CMS, hypothetically allowing companies to reduce the gap between obtaining FDA approval and a reimbursement decision.

"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.

Pilot Device

But like every pilot program, the Parallel Review program needs test projects to prove it can work. In March 2013, Medtronic made waves in regulatory circles by announcing that its Symplicity Renal Denervation Device would participate in the program. The device was widely seen as promising and likely to obtain approval.

The catheter-based procedure is 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 deactivating hyperactive nerves.

At the time, Medtronic said that its participation in the program was a "significant step forward in accelerating patient access to renal denervation in the US," but that its success would largely hinge on the results of an upcoming trial known as Symplicity HTN-3.

Device Failure, Program Failure?

But unfortunately for Medtronic-and FDA-that trial hasn't resulted in positive news for the device. In an announcement on 9 January 2014, the company said that the Phase III trial had not met its primary efficacy endpoint, marking a major setback for the device's hopes of receiving regulatory approval for its sought-after indication.

"Medtronic intends to formulate a panel of independent advisors made up of physicians and researchers who will be asked to make recommendations about the future of the global hypertension clinical trial program, as well as provide advice on continued physician and patient access to the Symplicity technology in countries with regulatory approvals," the company said in a statement.

But whether or not the device ultimately makes it to market under a different indication, the question for FDA may well be whether its vaunted pilot program can survive without its star test project. As Bloomberg noted in December 2013, only two companies have yet enrolled in the pilot program, in part because it has not yet been able to prove its worth.

The likely loss of one of those companies' devices could result in even less of an incentive for other companies to participate in the program.

Despite this, the failure of Medtronic' Symplicity device comes at a somewhat advantageous time. FDA recently extended the program for an additional two years based on the agency's expectation that the Symplicity device would be reviewed in either late 2014 or sometime in 2015. That additional time may now be used instead to find new candidates for the Parallel Review program-or decide if it's worth the trouble.

We reached out to FDA to see which other devices are currently enrolled in the program and will update this space if we hear back.

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