Ongoing follow-up of 266 randomized patients to inform final outcomes
TEWKSBURY, MA – May 14, 2026 – Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, today announced the completion of enrollment in the RESPONDER-HF clinical trial evaluating the Corvia® Atrial Shunt, with a total of 266 patients randomized. Following this milestone, further enrollment, randomization, and cross-over activities in the trial have been discontinued.
This action follows a recommendation from the independent Data Safety Monitoring Board (DSMB), with concurrence from the U.S. Food and Drug Administration (FDA), after a planned interim review of trial data. The DSMB noted that observed heart failure event rates were lower than anticipated, which may limit the ability to demonstrate a treatment effect within the current study design.
Importantly, the DSMB identified no safety concerns related to the device or the procedure.
The 266 randomized patients will continue to be followed per protocol, and ongoing data collection and analyses are expected to inform the final outcome of the study. Patients will remain blinded through the 24-month follow-up period.
“The completion of enrollment in RESPONDER-HF represents a significant milestone, and we are grateful to the patients, investigators, and study teams who made this trial possible,” said Jan Komtebedde, Chief Medical Officer of Corvia Medical. “We remain confident in the underlying scientific rationale for left atrial decompression and the potential for benefit in appropriately selected patients.”
Heart failure with preserved ejection fraction remains one of the largest and most complex areas in cardiovascular medicine. Prior data, including long-term outcomes from the REDUCE LAP-HF II trial, have suggested potential benefit in specific patient populations, supporting continued scientific interest in this approach.
Corvia remains committed to fulfilling clinical, regulatory, and patient safety obligations related to RESPONDER-HF and to completing follow-up and analysis of the trial data.
About Heart Failure and the Corvia Atrial Shunt
More than 26 million people worldwide have heart failure (HF), and the majority have heart failure with preserved ejection fraction (HFpEF), making it the largest unmet clinical need in cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated left atrial pressure (LAP), the primary contributor to HF symptoms in HFpEF patients, by creating a passage between the left and right atria, reducing HF events and improving quality of life.
About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. Visit https://corviamedical.com/.
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