Responder group patients with the shunt experience a 50% lower heart failure event rate and a 46% improvement in quality of life over control group
TEWKSBURY, MA – August 19, 2024 – Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the publication in JACC-HF of two-year data from the REDUCE LAP-HF II clinical trial of the Corvia® Atrial Shunt, affirming significantly improved outcomes from shunting among responder patients.
The study is a randomized, double-blind, placebo-controlled trial involving 626 patients diagnosed with heart failure with preserved or mildly reduced ejection fraction (HFpEF/mrEF), the largest unmet need in cardiology. The objective was to assess the safety and effectiveness of the Corvia Atrial Shunt in reducing HF-related hospitalizations and improving quality of life through a reduction in left atrial pressure, the primary cause of HF symptoms.
After two years of follow-up, the data confirmed a 50% reduction in heart failure events in previously defined responder patients – those with no latent pulmonary vascular disease or cardiac rhythm management device – compared to control, and a clinically meaningful 46% greater improvement in quality of life (KCCQ) over control, without any safety concerns.
“This is the first long-term, randomized data on atrial shunting in heart failure. The notable sustained improvement in heart failure symptoms and reduction in hospitalization through two years in responder patients who received the Corvia Atrial Shunt signify the potential of this therapy,” said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University School of Medicine and Global Heart Failure Investigator for the study. “The results confirm previous findings as to which patients are most likely to benefit from shunting as well as the safety of the procedure.”
“We’ve recently shown through two-year echocardiographic follow-up data that shunting improves cardiac structure and function in patients with responder characteristics, and now we’ve also confirmed the safety and positive quality-of-life impact over the same time frame,” said Martin Leon, MD, Director of Interventional Cardiovascular Care at Columbia University Irving Medical Center and Global Interventional Investigator for the study. “This important data should drive referrals of suitable patients to RESPONDER-HF, the confirmatory trial now underway in the US, Europe and Australia.”
Potential candidates are urged to visit https://treatmyheartfailure.com.
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. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. For information regarding RESPONDER-HF study eligibility, please visit https://treatmyheartfailure.com.
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, privately-held Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. Visit https://corviamedical.com.
MEDIA CONTACT:
Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com