41% reduction in heart failure hospitalizations and significant ongoing quality-of-life improvements for responder phenotype
TEWKSBURY, MA – March 3, 2026 – Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced positive five-year outcomes from the REDUCE LAP-HF II randomized clinical trial evaluating the Corvia® Atrial Shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. Results were presented at THT (Technology and Heart Failure Therapeutics) in Boston.
REDUCE LAP-HF II is the first and largest randomized device therapy trial conducted in heart failure patients with an ejection fraction ≥40% and provides the longest reported follow-up for atrial shunt therapy. The trial identified a large, phenotype-based responder group consisting of patients without latent pulmonary vascular disease or a cardiac rhythm management device.
At five years, responder patients treated with the Corvia Atrial Shunt experienced a 41% relative reduction in heart failure-related hospitalizations compared with control (18% vs. 30%, p=0.021). Patients were also 69% more likely to achieve a >20-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score versus control, reflecting clinically meaningful and sustained improvements in symptoms and physical limitations, including reduced shortness of breath and increased activity levels. Safety outcomes were comparable between treatment and control groups, supporting a consistent long-term safety profile.
“These five-year results reinforce the potential value of phenotype-guided therapy in HFpEF, with the defined responder group continuing to demonstrate sustained efficacy, durable benefit, and a reassuring safety profile with atrial shunting,” said Dr. Sanjiv Shah, Director of Research for the Bluhm Cardiovascular Institute and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine. “The continued separation of heart failure event curves through five years of follow-up supports evidence of durable improvements in health status and helps address prior theoretical concerns regarding potential late right heart volume overload associated with interatrial shunting. Based on the data collected in the trial, we have not found evidence of late right-sided heart failure in patients in the responder group randomized to receive the atrial shunt device.”
“REDUCE LAP-HF II is the only randomized atrial shunt trial with 5-year follow-up, providing critical insight into long-term outcomes and durability,” said Jan Komtebedde, Chief Medical Officer at Corvia Medical. “We continue driving toward completion of RESPONDER-HF, a sham-controlled confirmatory trial designed to validate these findings in a well-defined responder phenotype and support FDA approval of the Corvia Atrial Shunt.”
About heart failure (HF) and the Corvia Atrial Shunt
More than 26 million people worldwide have HF, and the majority have 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/. For information regarding RESPONDER-HF study eligibility, please visit https://treatmyheartfailure.com.
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