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Two years of echocardiographic data affirm positive effects of atrial shunt therapy on heart structure and function
TEWKSBURY, Mass., May 8, 2024 /PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the publication in JAMA Cardiology of two-year echocardiographic data from its REDUCE LAP-HF II randomized clinical trial of the Corvia® Atrial Shunt, offering groundbreaking insight into the impact of a shunt on the heart.
The study demonstrated favorable long-term effects of atrial shunting on heart structure and function in patients with heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF). Analysis showed that atrial shunting led to favorable cardiac remodeling, restoration of the heart's normal function, with resulting improvements in clinical outcome and prognosis.
The analysis also demonstrated more favorable remodeling in previously defined responders compared to non-responders, confirming that patients with no latent pulmonary vascular disease and no cardiac pacemaker are most likely to benefit from atrial shunt therapy.
"We now have two-year evidence of reverse remodeling in patients with an atrial shunt, with more pronounced improvements in cardiac structure and function — and associated clinical benefit — in previously defined responders versus non-responders," said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University School of Medicine and lead investigator for the study. "This data not only offers insight into the long-term effects of atrial shunting but also represents the largest and most comprehensive echocardiographic follow-up study of any device or pharmacological trial in HFpEF and HFmrEF to date.
"The findings of our study support the referral of suitable patients to RESPONDER-HF, a randomized, sham-controlled trial now underway in the US, Europe and Australia in pursuit of the evidence required to achieve FDA approval of the Corvia Atrial Shunt for millions of heart failure 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. 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
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