Cardiologist questions FDA’s approval process for high-risk medical devices
The technology used to diagnose, treat and manage cardiovascular disease is always evolving. The next big thing, it seems, is always just around the corner—and the next big thing after that is never far behind.
This trend has kept the U.S. Food and Drug Administration (FDA) busy over the years. The agency regularly approves new cardiac and cardiovascular devices, including those uses by general cardiologists and specialists in interventional cardiology, structural heart disease, cardiac surgery, heart failure and electrophysiology.
These approvals are an essential piece of the modern cardiology landscape—but one cardiologist is worried that the FDA’s standards may be too lax when it comes to reviewing high-risk medical devices.
Sanjay Kaul, MD, a cardiologist with Cedars-Sinai Medical Center in Los Angeles, shared his perspective in JACC: Cardiovascular Interventions, an American College of Cardiology journal.[1] Kaul pointed to several recent examples to make his point. He started with the 2024 approvals of the Evoque transcatheter tricuspid valve replacement system from Edwards Lifesciences and the TriClip transcatheter edge-to-edge valve repair system from Abbott.
“Both devices significantly reduced tricuspid regurgitation (TR) grade to moderate or less,” Kaul wrote. “However, there was no difference in mortality, tricuspid valve surgery, hospitalization for heart failure, biomarker N-terminal pro–B-type natriuretic peptide or intensity of medical therapy. Thus, two new transcatheter devices were approved for TR driven primarily by patient-reported outcomes, which are prone to bias or placebo effect in unblinded trials.”
In addition, he added, the TriClip device was approved with input from an advisory panel, and the Evoque device was not.
Kaul also examined the 2023 FDA approvals of the Paradise Ultrasound renal denervation (RDN) system from Recor Medical and Symplicity Spyral RDN system from Medtronic, noting that a key advisory panel had endorsed the Paradise Ultrasound device, but not the Symplicity Spyral device. In addition, he added, both offerings were only associated with “modest” reductions in systolic blood pressure.
Exploring the recent history of FDA approvals
Kaul then detailed other examples from 2013 to the present day that highlight what he sees as a growing trend of cardiac devices gaining approval “despite either equivocal or negative findings in their pivotal trials.” His list included, among others, the MitraClip delivery system from Abbott Medical and the Watchman device from Boston Scientific.
From Kaul’s perspective, these device approvals suggest the current bar for FDA approval is “too low.”
“The FDA’s mission of promoting innovation and protecting public health is best served by exercising sufficient caution in mitigating bias in device trials and ensuring reasonable assurance of safety and effectiveness before allowing these devices to be marketed,” he wrote. “The FDA must ensure timely launch (preferably at the time of approval) and completion of post approval studies. Finally, the FDA should be incentivized to exercise its newly legislated authority by the Congress via the Food and Drug Omnibus Reform Act of 2022 to revoke approval of devices that fail to complete post approval studies in a timely manner or fail to confirm clinical benefit in post approval studies.”
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.