Corvia's RESPONDER-HF Confirmatory Trial Supported by RELIEVE-HF Data

Second major trial for atrial shunt therapy demonstrates importance of patient selection

TEWKSBURY, Mass., April 12, 2024 /PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, welcomes the recent release of V-Wave's RELIEVE-HF trial data supporting the evidence base around atrial shunt therapy, which is currently under study in the global RESPONDER-HF trial of the Corvia^® Atrial Shunt.

RELIEVE-HF failed to meet its primary efficacy endpoint and did not reduce heart failure events or improve quality of life in heart failure patients with a preserved ejection fraction (HFpEF). However, the results confirmed the importance of selecting patients with characteristics likely to benefit from atrial shunting versus those who will not.

"Patient selection is critical, especially in HFpEF," said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University School of Medicine, and co-Principal Investigator of RESPONDER-HF. "We found in our last trial, REDUCE LAP-HF II, that HFpEF patients with pacemakers or pulmonary vascular disease didn't benefit from atrial shunting. In our ongoing RESPONDER-HF trial we are excluding those patients and using exercise hemodynamics to qualify and randomize HFpEF patients most likely to respond favorably to shunting."

"In this emerging field, it's crucial to recognize the nuances of different studies with respect to patient demographics and trial methodologies to prevent misinterpretation of findings," said Martin Leon, MD, Director of Interventional Cardiovascular Care at Columbia University Irving Medical Center and co-Principal Investigator of RESPONDER-HF. "We know shunting is safe and has a positive effect in appropriately selected patients with HFpEF, and we have three-year data to prove it. We're confident the ongoing RESPONDER-HF trial will be a definitive step forward in bringing atrial shunt therapy to millions of HFpEF patients."

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. Visit https://corviamedical.com. For information regarding RESPONDER-HF study eligibility, please visit https://treatmyheartfailure.com.

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