Healthcare Industry News:  Edwards Lifesciences 

Devices Interventional Cardiology FDA

 News Release - November 17, 2020

Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt

Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment

TEWKSBURY, Mass., Nov. 17, 2020 -- (Healthcare Sales & Marketing Network) -- 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® 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."

About Heart Failure

Heart failure (HF) is a chronic condition that affects approximately 26 million people worldwide. By 2030, that number will increase by almost 50%, to nearly 38 million people. More than half of all HF patients have HFpEF/HFmrEF, and that number is increasing, driven by population aging and other risk factors. In patients with HFpEF/HFmrEF, 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, causing an increase in pressures in the left heart chambers and the lungs. HFpEF/HFmrEF remains one of the most significant unmet needs in cardiovascular medicine. While there have been significant advances in treatment for heart failure with reduced ejection fraction (HFrEF), there currently are no effective treatments for HFpEF/HFmrEF.

About the Corvia Atrial Shunt (IASD®)

The Corvia Atrial Shunt is a novel, transcatheter implant for patients suffering from symptomatic heart failure (HF) and the first therapeutic device designed to directly address elevated left atrial pressure (LAP), the primary contributor of HF symptoms. The device (about the size of a dime) 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 passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering LAP and pressure in the lungs. By facilitating continuous and dynamic decompression of the left atrium, the Corvia Atrial Shunt aims to improve HF symptoms and quality of life, decrease HF hospitalizations, and reduce the overall cost of managing HF patients. The Corvia Atrial Shunt is the most clinically studied interatrial shunt for the reduction of LAP in symptomatic HF patients. It has been implanted in more than 400 patients worldwide and reviewed in over 20 publications. For more information, visit The Corvia Atrial Shunt is an investigational device and is not available for commercial distribution in the 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 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.

For more information, visit

Source: Corvia Medical

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