LANDMARK REDUCE LAP-HF II TRIAL DEMONSTRATES CLINICAL BENEFITS OF CORVIA® ATRIAL SHUNT IN A LARGE SEGMENT OF HEART FAILURE PATIENTS
The REDUCE LAP-HF II trial is the world’s first Phase III trial to evaluate an atrial shunt in heart failure patients to reduce symptoms of HF, decrease HF-related hospitalizations and improve quality of life by reducing left atrial pressure (LAP). A total of 626 patients were randomized at 89 centers across the United States, Canada, Europe, Australia, and Japan. Patients with a normal exercise PVR, indicating the absence of pulmonary vascular disease (PVD), and without a pacemaker, achieved significant clinical benefit, including a reduction in heart failure events compared to sham (0.12 versus 0.22 events per patient-year, p = 0.007) and significant and clinically significant difference in health status improvement compared to sham (+5.5 points) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) global score.1
“Prior to this study, we knew that patients with significant PVD would be highly unlikely to benefit from atrial shunt therapy. However, we have not fully appreciated the critical role that invasive exercise phenotyping may have in finding the degree of PVD that allows patients to benefit from an atrial shunt,” added Barry Borlaug, MD, Professor of Medicine and Director of Circulatory Failure Research at Mayo Clinic. “Although further study is needed, with appropriate patient selection, atrial shunt may be an excellent option for HFpEF patients without any form of PVD. In REDUCE LAP-HF II, patients treated with a vasculature exercise-confirmed normal lung disease, had a significantly higher likelihood of clinical benefit than the sham control, with a lower rate of HF events and significant, clinically meaningful improvement in KCCQ.”
More than 26 million people worldwide suffer from heart failure,2 and more than half of them have HFpEF,3 which has been described as the greatest unmet clinical need in cardiovascular medicine. “These data have important implications not only for the Corvia atrial shunt, but also for ongoing and future trials using atrial shunt devices and procedures to treat heart failure,” said Martin Leon, MD, Professor of Medicine and Director of Interventional Cardiovascular Care at Colombia University Irving Medical Center and Co-Principal Investigator of the REDUCE LAP-HF II trial.
“We are proud that REDUCE LAP-HF II has led us to a major clinical breakthrough in HFpEF and we are working closely with our clinical advisors and regulators to expand access to this new therapy,” said Jan Komtebedde. , senior vice president and medical director. Officer of Corvia Medical. Added george fazio, CEO of Corvia Medical, “For the past 12 years, Corvia Medical has been dedicated to bringing the atrial shunt to the millions of heart failure patients who could benefit from it, and we have now taken a giant step to make of our mission a reality.”
About heart failure
Heart failure (HF) is a chronic disease that affects approximately 26 million people worldwide. By 2030, this number will increase by almost 50%, to nearly 38 million people. More than half of all patients with heart failure have HFpEF/HFmrEF, and this number is increasing, due to the aging population and other risk factors. In these patients, the proportion of blood pumped out of the heart is normal or relatively normal, but because the muscles of the left atrium and ventricle are stiff, the heart cannot relax and fill properly, resulting in increased pressures in the left heart chambers. and the lungs. HFpEF/HFmrEF remains one of the greatest unmet needs in cardiovascular medicine. Although there have been significant advances in the treatment of heart failure with reduced ejection fraction (HFrEF), there are limited treatment options for HFpEF/HFmrEF.
About the Corvia Atrial Shunt (IASD®)
The Corvia Atrial Shunt is a novel transcatheter implant for patients with symptomatic heart failure (HF) and the first therapeutic device designed to directly treat elevated left atrial pressure (LAP), the primary contributor to HF symptoms. The device (about the size of a penny) is implanted by an interventional cardiologist or electrophysiologist during a minimally invasive outpatient procedure. After a small opening is created in the atrial septum, the Corvia Atrial Shunt is deployed, forming a passageway between the left and right atria that allows the left atrium to decompress at rest and during physical activity, in the purpose of lowering the LAP and the pressure in the lungs. By facilitating continuous, dynamic decompression of the left atrium, the Corvia Atrial Shunt aims to improve HF symptoms and quality of life, reduce hospitalizations for HF, and reduce the overall cost of managing HF. HF patients. The Corvia Atrial Shunt is the most clinically studied atrial shunt for LAP reduction in symptomatic HF patients. It received Breakthrough Device Designation from the FDA in 2019. The Corvia Atrial Shunt is an investigational device and is not available for commercial distribution in United States. The device is available for sale in the European Union.
About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure with new transcatheter cardiovascular devices. Founded in 2009 and based in Tewksbury, MA, Corvia Medical is dedicated to transforming the standard of care for the treatment of heart failure, empowering patients to take charge of their lives. 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 https://corviamedical.com/.
- REDUCE LAP-HF II 12-Month Primary Endpoint Report Addendum, Baim Institute 2022-01-18.
- Savarese G, Lund LH. Global public health burden of heart failure. Card Fail Rev. 2017;3(1):7-11.
- Owan TE, Hodge DO, Herges RM, et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251-259.
SOURCECorvia Medical, Inc.