(Information sent by the signatory company)
Corvia® Atrial Lead May Change Heart Failure Treatment
TEWKSBURY, Mass., Dec. 6, 2022 /PRNewswire/ -- Corvia Medical, a company dedicated to transforming the treatment of heart failure (HF), has announced that the first patient has been randomized in RESPONDER-HF, a global trial Corvia atrial shunt confirmation in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.
The first patient was enrolled and randomized by interventional cardiologist Scott Lilly, MD, and Rami Kahwash, MD, heart failure cardiologist at The Ohio State University Wexner Medical Center. "We are pleased to participate in RESPOND-HF and continue the important work of studying atrial shunt therapy, which may have significant clinical benefit for millions of heart failure patients," commented Dr. Lilly. Dr. Kahwash added: "Despite continued pharmaceutical advances, the treatment of HFpEF remains challenging, and multiple therapies are needed to treat such a heterogeneous disease. We are pleased to offer access to a new therapeutic option that may alleviate dyspnea in our patients and improve their quality of life".
RESPOND-HF is a randomized, sham-controlled trial that includes up to 260 patients from 60 centers in the United States, Europe, and Australia. The trial will assess the efficacy of the Corvia atrial shunt in reducing HF hospitalizations and improving quality of life. Dr. Sanjiv Shah, Director of Research at the Bluhm Cardiovascular Institute and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, and Dr. Martin Leon, Director of Interventional Cardiovascular Care at the University of Irving Medical Center Columbia, are the study's principal investigators.
The confirmatory RESPONDER-HF trial builds on the extensive scientific data and progressive learnings from REDUCE LAP-HF II, the largest randomized controlled trial of a device-based treatment for patients with HFpEF. As published in Circulation1, REDUCE LAP-HF II is the only study of an implantable therapeutic device that has shown clinical benefit in this population. In the large group of responders, representing 50% of the study patients, treatment with the Corvia atrial lead resulted in a 45% reduction in HF episodes and an improvement in quality of life 55% greater compared to the sham control.
"We are determined to demonstrate the potential benefit of atrial shunt therapy and anticipate that RESPONDER-HF will validate the results of the REDUCE LAP-HF II responder group, which corresponds to two-thirds of people with HFpEF, or 2 million of people in the United States alone," said Dr. Leon. Dr Shah added: "The RESPONDER-HF trial will not only further advance our scientific understanding of shunting in HFpEF, but also has the potential to change the treatment paradigm, and in doing so bring us one step closer to precision medicine in heart failure".
More than 26 million people worldwide suffer from HF2, and the majority have HFpEF3, the largest unmet clinical need in cardiovascular medicine. The Corvia atrial shunt is designed to reduce elevated left atrial pressure (LDAP), which is the main cause of HF symptoms in patients with HFpEF. The shunt is placed through a catheter between the left and right atria, forming a conduit that allows blood to flow from the high-pressure left atrium to the low-pressure right atrium, with the goal of reducing symptoms and events of HF and improve quality of life.
About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure with 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 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. For more information, visit the website https://corviamedical.com/.
For information about eligibility to participate in the RESPONDER-HF study, visit https://treatmyheartfailure.com.
MEDIA CONTACT:
Lisa Ensz 1 978-654-6120lensz@corviamedical.com https://corviamedical.com/newsroom/
1.Borlaug BA et al. Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure. Circulation. 2022;10.1161.
2.Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017;3(1):7-11.
3.Owan TE et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251-259
Photo - https://mma.prnewswire.com/media/1007933...Logo - https://mma.prnewswire.com/media/224540/...
View original content: https://www.prnewswire.com/news-releases/corvia-medical-anuncia-la-aleatorizacion-del-primer-paciente-del-ensayo-confirmatorio-responder-hf-301696217.html
