FDA Panel Rejects Interatrial Shunt for Heart Failure
december 04, 2025 | 3 min read
Key takeaways:
- An FDA advisory panel voted 0-15 against approving an interatrial shunt to improve symptoms and prognosis in patients with HF.
- The panel determined there was a lack of ‘overwhelming evidence of benefit.’
The FDA’s Circulatory System Devices Panel voted not to recommend approving use of an interatrial shunt to treat patients with heart failure (HF),finding a lack of compelling evidence to support its benefits.The vote was unanimous, with 15 members voting against approval and zero in favor.
the device, manufactured by Corvia Medical, is designed to create a controlled pathway for blood to flow between the left and right atria of the heart.The intention is to reduce pressure in the pulmonary circulation, potentially alleviating symptoms and improving outcomes for patients with HF.
During the panel meeting, experts expressed concerns about the study design and the limited evidence demonstrating a clear benefit.While some data suggested improvements in certain HF symptoms, the panel concluded that the evidence was not “overwhelming” enough to justify the risks associated with the procedure.
“The panel felt that the data presented did not demonstrate a clinically meaningful benefit that would outweigh the potential risks of the procedure,” a panel member stated following the vote. “More robust evidence is needed to establish the safety and efficacy of this device.”
The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does. A final decision on the approval of the interatrial shunt is expected in the coming months.
FDA Panel Raises Concerns Over Interatrial Shunt Device
During a recent hearing, the FDA’s Circulatory System Devices Panel expressed reservations regarding the efficacy and long-term safety of a novel interatrial shunt device intended for patients with heart failure and preserved ejection fraction. While acknowledging the procedure appeared safe in the immediate periprocedural period, panel members debated whether the available data sufficiently demonstrated a clinical benefit.
“The primary endpoints might potentially be considered hypothesis-generating and should be interpreted with caution,” the panel noted.
“Like some others, I struggled with safety more than efficacy. Periprocedurally, this appears to be a safe procedure. I do have concerns about the long-term effects with regards to efficacy,” paul J. Hauptman, MD, dean and professor at University of Nevada, Reno School of Medicine, said during the hearing. “It comes down to the fact that I was not prepared to abandon the primary endpoint, because otherwise why have a primary endpoint in a study, if you then drill down and find signals elsewhere. You live by the primary endpoint; you die by it too.”
James Blankenship,MD,professor of medicine,director of cardiac catheterization laboratory and director of division of cardiology at the University of New Mexico,echoed these concerns. “As for the efficacy, I voted no for the reasons that have been stated: small data set. The sponsors are asking us to look at a data set that is hypothesis-generating and believe that the data is so convincing that we can be certain that it shows efficacy,” blankenship said. “This is a therapy that would be incrementally beneficial, superimposed on a field where we’re already making pretty constant improvements in therapy. The penalty for making the wrong decision hear doesn’t outweigh the fact that we just don’t know if it’s efficacious and providing a procedure that doesn’t work … would not be ethical.”
The interatrial shunt received a CE mark and is approved to be marketed for use in the European Union but is not yet approved for commercial use in the U.S.
The FDA is not required to follow recommendations of its advisory committees, but it usually does.
Published by: Cardiology Today
Sources/Disclosures
Source: FDA. Circulatory System Devices Panel meeting.
References: Available upon request.
Disclosures: Available upon request.
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