Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt
Pubblicato il: 17/11/2020 12:00
Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment
TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ -- Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia
REDUCE LAP-HF II is the world's first large, prospective, multicenter, randomized, sham-controlled trial to evaluate interatrial shunting. The study randomized 626 patients at 109 sites across 15 countries, with the aim to improve quality of life, reduce HF symptoms and decrease HF-related hospitalizations. Primary outcome measures will be evaluated after the last randomized patient completes 12-month follow-up. Sanjiv Shah, MD from Northwestern University Feinberg School of Medicine in Chicago, Illinois, and Martin Leon, MD from the Columbia University Irving Medical Center in New York, NY serve as lead principal investigators.
"The outcome of the landmark REDUCE LAP-HF II trial has the potential to revolutionize how we treat these heart failure patients, which is the greatest unmet need in cardiology today," stated Sanjiv Shah, MD. "Treating this population is challenging, and often frustrating, because standard treatments for heart failure don't work well. Data from this study evaluating the efficacy of the Corvia Atrial Shunt will provide valuable information regarding this novel therapy in this underserved patient population." Martin Leon, MD added, "In light of the increasing incidence of heart failure, innovative treatment options are of critical importance. We are pleased with the study execution and enrollment pace of this trial, and are eagerly awaiting the results, which have the potential to change the treatment paradigm for heart failure."
"Randomizing the last pivotal trial patients is a significant milestone for Corvia and brings us one step closer to providing this innovative technology to patients in the US," said George Fazio, President and CEO of Corvia Medical. "REDUCE LAP-HF II is one of the largest randomized heart failure device trials ever undertaken and demonstrates our commitment to building a strong body of clinical evidence showing how atrial shunting advances care for patients suffering with the debilitating symptoms of heart failure."
Corvia also announced FDA authorization to continue patient enrollment under a CAP. The open label REDUCE LAP-HF IV study will enroll patients at existing pivotal trial centers. "We are pleased to have the opportunity to continue to offer this breakthrough therapy to heart failure patients," said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. "In collaboration with our advisors and investigators, we are committed to generating unbiased evidence to support this new therapeutic class of atrial shunting for heart failure. This study provides an opportunity to generate additional safety and efficacy evidence to support future therapy adoption."
About Heart FailureHeart failure (HF) is a chronic condition that affects approximately 26 million people worldwide.
About the Corvia Atrial Shunt (IASD
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 Medical is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim 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.
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