High-Risk Heart Devices Receive FDA Approval Despite Scarce Scientific Evidence

By Emily Cox
heart devices
flickr/Christopher Mance

A new study confronts significant issues with medical device approval in the US, underlining more than a dozen instances federal regulators approved heart devices under its “Priority Review” process that were later found to be dangerous and ineffective.

JAMA Internal Medicine published the study August 27. University of California San Francisco School of Medicine researchers found that the FDA relied on studies with little scientific evidence to establish cardiovascular devices were safe or even effective before approving them through its “Priority Review” program.

The report analyzed randomized clinical trials manufacturers performed to provide evidence for premarket approval from the FDA for heart devices. Researchers found that, as devices move through the Priority Review program, the quality and thoroughness of scientific evidence to justify approval of products is not known, let alone evaluated.

The researchers evaluated evidence manufacturers provided federal regulators for 14 high-risk cardiovascular devices that received FDA approval under its Priority Review program between 2007 and 2017. During that time, federal regulators approved a total of 29 devices under the fast-track program. Of these, 14 were high-risk heart devices. Manufacturers used a total of 18 studies to support that these devices were safe and effective.

The findings indicate that none of the 18 studies were double-blind trials. This research benchmark is generally considered essential for high-quality data. At least 13 of the studies used surrogate end points. Furthermore, none of the studies were large-scale, enrolling only an average of 500 patients.

Heart Devices Point to Regulatory Failings

In total, the FDA convened nine safety expert advisory panels to review the effectiveness and safety of the heart devices. Four of these panels found that the devices were safe. However, they did not find the devices were effective in treating the cardiovascular problems at issue. But, regulators pushed the devices through anyway. For 13 of the 14 devices, the FDA asked for post-approval studies for further information.

As of May 23, 2018, there have been two Class I and 13 Class II recalls for six of the heart devices. Earlier this year, Medtronic heart implants, which were among the products covered in the recent report, were recalled because of defects that stopped the devices from providing life-saving shocks.

Study authors warn that the majority of the recalled heart devices received approval based on a single nonrandomized, non-blinded study. They are calling for regulators to make some changes to Priority Review during premarket approval.

“To lower the odds of recall the new program should demand high-quality pre-approval data, larger scale studies, and longer followup,” researchers wrote.

Study Authors Call for Regulatory Changes

The push for high-quality research for approvals stands diametrically opposed to the FDA’s recent efforts to make medical device approvals ever easier and faster. This year the FDA also announced an action plain to spur innovation by further streamlining the premarket and post-market process.

Bringing devices to market faster along with the integration of the premarket and post-market processes only deepens already substantial concerns that patients will pay the ultimate price for devices coming to market through a rushed and ineffective approval process.

Consequently, researchers are calling for the FDA to take action to ensure that post-market studies are completed within a specified time limit. This way, if any problems are revealed, like those that could warrant a recall, the post-market study might help pick up these problems before a significant number of patients are harmed.


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