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Corvia Medical publishes the results of a two-year clinical trial to confirm the sustained benefit and safety of atrial shunt in patients with heart failure.
A phase I randomized controlled trial of atrial shunt therapy shows continued benefit
Tewkesbury, Requiem.And May 22, 2023/PRNewswire/ — Medical CorviaAnd a companya company dedicated to transforming the treatment of heart failure cardiac musclesToday she announced the results of two years of her clinical trial random decrease Lab – HF II Confirmation of safety and efficacy of atrial shunt Corvia® in patients with insufficiency cardiac muscles correctly with part of eviction saved (HFpEF) or slightly reduced (HFmrEF). Results presented today at the conference Heart failure 2023 from the European Society of Cardiology (Exit) in Prague, Czech Republic, showed that patients who experienced a clinical benefit in one year continued the benefit for two years.
“Results from the two-year REDUCE LAP-HF II test show the long-term safety of Corvia atrial shunt and support what we observed at one year, which is that in appropriately selected patients, atrial shunt appears to have a lasting clinical benefit in reducing failure events.” Finn Gustafson, MD, professor of cardiology at the University of Copenhagen. “This is the first long-term randomized data available for any atrial bypass device, and it continues to suggest that heart failure patients with 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 effectiveness of atrial shunting in patients with heart failure. The study of 626 former patients 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, interest was maintained in this group for two years. Patients with the atrial lead Corvia, which is implanted between the left and right atria, showed a significant 50% reduction in the incidence of HCV and a sustained improvement in quality of life compared to placebo control, with a 42% greater improvement in cardiomyopathy in KS . Summary Score Questionnaire (KCCQ).
“The results of the 24-month REDUCE LAP-HF II trial provide further confirmation of the safety and efficacy of atrial Corvia driving,” he noted. Sanjeev ShahHe holds MD from Northwestern University Feinberg School of Medicine and co-principal investigator of the trial. “As ongoing global trials continue to increase our knowledge of atrial shunt, I remain optimistic that this device has the potential to provide significant long-term benefits for a large percentage of patients with heart failure.”
“We are excited about the two-year results in the response cohort because they provide strong evidence that we have successfully identified patients with heart failure who would benefit most from atrial shunting,” explained Jean Comtepied, Corvia’s chief medical officer. “We are currently recruiting patients for the RESPONDER-HF study, which is a validated, randomized, placebo-controlled trial in up to 60 centers in the United States, Europe, and Australia. We believe the results of this trial will provide the additional evidence needed to make the treatment available to a wider audience of patients.”
About heart failure (HF) and atrial corvia 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), a major factor contributing to symptoms of heart failure in HFpEF patients, by creating a passage between the right and left atria, thus reducing the incidence of heart failure and improving quality of life.
About Corvia Medical, Inc.
Corvia Medical, Inc. Revolutionizing the treatment of heart failure with new transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewkesbury, MassachusettsCorvia is dedicated to transforming the standard of care for the treatment of heart failure, enabling patients to take their lives back. Corvia Atrial Lead received a Breakthrough Device designation from the FDA in 2019. It is a privately owned company, backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumera Ventures, Edwards Live Science and an undisclosed strategic investor about him. visited https://corviamedical.com/.
For more information on RESPONDER-HF study eligibility, visit https://treatmyheartfailure.com.
Media connectionLisa Innes+1 978-654-6120[email protected]