- Corvia Medical publishes the results of the two-year clinical trial confirming the sustained benefit and safety of its atrial shunt in patients with heart failure
First Phase III Randomized Controlled Trial of Atrial Shunt Therapy Shows Continued Benefit
TEWKSBURY, Mass., May 22, 2023/PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the two-year results of its REDUCE LAP-HF II randomized clinical trial that confirm the safety and sustained efficacy of the Corvia® atrial shunt in appropriately selected heart failure patients with preserved or mildly reduced ejection fraction (HFpEF) (HFmrEF). Results presented today at the European Society of Cardiology (ESC) Heart Failure 2023 conference in Prague, Czech Republic, confirmed that patients who experienced clinical benefit at one year continue to benefit at two years.
"The two-year results of the REDUCE LAP-HF II demonstrate the long-term safety of the Corvia atrial shunt and support what we observed at one year, that in appropriately selected patients, the atrial shunt appears to have lasting clinical benefit in reducing of event failures," said Finn Gustafsson, MD, professor of cardiology at the University of Copenhagen. "This is the first long-term randomized data available for any atrial bypass device, and continues to suggest that heart failure patients with more normal pulmonary vascular function are best suited for atrial bypass."
REDUCE LAP-HF II is the world's first Phase III trial to evaluate the safety and efficacy of an atrial shunt in patients with heart failure. 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 lead, which is implanted between the left and right atria, showed a significant 50% reduction in HF event rate and a sustained improvement in quality of life compared with sham control, with a 42% greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.
"The 24-month results of the REDUCE LAP-HF II trial provide further assurance of the safety and efficacy of the Corvia atrial lead," said Sanjiv Shah, MD, of Northwestern University Feinberg School of Medicine and co-principal investigator of the trial. . "As ongoing global trials continue to increase our knowledge of atrial shunting, I remain optimistic that this device has the potential to provide significant long-term benefits to a large proportion of heart failure patients."
"We are excited about the two-year results in the response group as they provide strong evidence that we have successfully identified heart failure patients who will benefit most from atrial shunting," explained Jan Komtebedde, Corvia's chief medical officer. Medical. "We are currently recruiting patients for the RESPONDER-HF study, a confirmatory, randomized, sham-controlled trial at up to 60 centers in the United States, Europe, and Australia. We believe that the results of this trial will provide the additional evidence needed to make the therapy is available to a broader patient population.
About Heart Failure (HF) and the Corvia Atrial Lead
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 main factor contributing to heart failure symptoms in patients with HFpEF, by creating a passage between the left and right atria, reducing heart failure events and improving the quality of life.
About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through new 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 take back their lives. The Corvia Atrial Lead received FDA Breakthrough Device Designation 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 more information on eligibility for the RESPONDER-HF study, visit https://treatmyheartfailure.com.
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