Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia Atrial Shunt (IASD) – a novel, transcatheter implant – to reduce elevated left atrial pressures (LAP), the primary cause of HF symptoms, in heart failure patients with preserved ejection fraction (HFpEF) or mid-range ejection fraction (HFmrEF). The company also announced authorization by the Food and Drug Administration (FDA) to continue evaluation of the Corvia Atrial Shunt under a Continued Access Protocol (CAP) while its pre-market approval (PMA) application is under review. PMA submission is planned for late 2021.

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."