44% reduction in total heart failure event rate and ongoing improvements in quality of life in responder group patients implanted with shunt
TEWKSBURY, Mass., Oct. 25, 2024 /PRNewswire/ — Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced impressive three-year results from its REDUCE LAP-HF II randomized clinical trial confirming safety and sustained efficacy of the Corvia® Atrial Shunt in selected heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. The results were published in The American Heart Journal.
REDUCE LAP-HF II is the world’s first phase III trial to evaluate safety and efficacy of an atrial shunt in heart failure patients. The study of 626 patients previously identified a responder group representing half of all study participants. This group consisted of patients without latent pulmonary vascular disease or a cardiac rhythm management device.
At three years, the 161 responder patients receiving the Corvia Atrial Shunt experienced 44% fewer combined inpatient and outpatient heart failure events compared to the control group of 152 patients. The shunt group also reported a clinically meaningful 2.5 times greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, indicating improved quality of life with less fatigue, reduced shortness of breath, and fewer activity restrictions. No significant safety concerns have been identified with the Corvia Atrial Shunt.
"What we’ve learned from this three-year data set is that the Corvia shunt results are not only strongly positive but demonstrably durable," said Sheldon Litwin, MD, Alicia Spaulding-Paolozzi Professor of Cardiology at Medical University of South Carolina and a lead researcher in the trial. "The absolute risk reduction for total heart failure events actually improves year by year over the two-year and one-year statistics. And with a majority of patients emphasizing quality of life even over reduced hospitalizations, the importance of the sharply improved KCCQ scores is magnified."
"We are confident that the strong three-year results will generate continued enthusiasm for atrial shunting among referring physicians, positioning it as a promising treatment option for eligible HFpEF patients," said Jan Komtebedde, Chief Medical Officer at Corvia Medical.
"We are actively driving toward completion of RESPONDER-HF, a randomized, sham-controlled, confirmatory trial conducted at up to 80 centers worldwide," added George Fazio, Chief Executive Officer at Corvia Medical, "which we expect to generate the final data set needed for 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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