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FIRST-EVER PHASE III RANDOMIZED CONTROLLED TRIAL OF ATRIAL SHUNT THERAPY SHOWS CONTINUED PROMISE
TEWKSBURY, Mass., May 22, 2023 /PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced two-year results from its REDUCE LAP-HF II randomized clinical trial confirming safety and sustained efficacy of the Corvia® Atrial Shunt in properly selected heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. The results presented today at the European Society of Cardiology (ESC) Heart Failure 2023 conference in Prague, Czech Republic confirmed that patients who experienced a clinical benefit at one year continue to benefit at two years.
"The two-year REDUCE LAP-HF II findings demonstrate the longer-term safety of the Corvia Atrial Shunt and support what we observed at one year, that in properly selected patients, atrial shunting appears to have lasting clinical benefit in the reduction of heart failure events," said Finn Gustafsson, MD, Professor of Cardiology, University of Copenhagen. "This is the first longer-term, randomized data available for any atrial shunt device, and it continues to suggest that heart failure patients with more normal pulmonary vascular function are best suited for atrial shunting."
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, who experienced a significant reduction in heart failure events and an improvement in quality of life at one year. Importantly, the benefit was sustained in this group at the two-year mark. Patients with the Corvia Atrial Shunt, which is implanted between the left and right atria, showed a significant 50% reduction in the rate of HF events and a sustained improvement in quality of life compared to sham control, with 42% greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.
"The 24-month results from the REDUCE LAP-HF II trial provide further assurance of the safety and efficacy of the Corvia Atrial Shunt," said Sanjiv Shah, MD, Northwestern University Feinberg School of Medicine, co-principal investigator of the trial. "As ongoing global trials continue to advance our knowledge of atrial shunting, I remain optimistic that this device has the potential to deliver significant long-term benefits to a large proportion of heart failure patients."
"We are excited about the two-year outcomes in the responder group as they provide strong evidence that we have successfully identified those heart failure patients who will benefit most from atrial shunting," said Jan Komtebedde, Chief Medical Officer at Corvia Medical. "We are currently recruiting patients into the RESPONDER-HF study, a confirmatory, randomized, sham-controlled trial at up to 60 centers across the US, Europe, and Australia. We believe the results from this trial will provide the additional evidence required to make the therapy available to a broader patient population."
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.
Media contact
Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com
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