In heart failure with preserved ejection fraction, the failure of the leading atrial shunt developer’s pivotal trial hasn’t dampened investor and strategic interest in the space; it merely underscored the heterogeneity of the patient population. Early movers are now in the process of defining subgroups of responders that still represent large markets. Meanwhile, two newer companies—Axon Therapies and Artract Medical—hope to operate on mechanisms that act more broadly in this complex disease.
In the past 20 years, a subset of heart failure known as heart failure with preserved ejection fraction or HFpEF (colloquially pronounced “heff peff”), has emerged as a disease of aging that’s on the rise. It represents an enormous unmet clinical need since, for the most part, patients with HFpEF don’t respond to any of the myriad heart failure treatments developed by the pharmaceutical or medical device industries. No drugs, circulatory assist devices, implantables for cardiac rhythm management, or devices that remodel the heart have proven to reduce hospitalizations or mortality in this patient population.
HFpEF is still very much a white space opportunity; these patients represent fully half of all heart failure diagnoses, or 70% of heart failure diagnoses in people between the ages of 65 and 84. With a 26 million global incidence of heart failure, broadly speaking, that’s a significant unmet need and an enormous potential market for therapy developers, many of whom have been working at it for more than a decade.
Founded in 2009, pioneer Corvia Medical Inc. set out to develop the first interventional device designed for HFpEF, an implant that addresses the elevated left atrial pressures that occur in most HFpEF patients during exercise. The implant shunts blood from the high pressure left atrium to the lower pressure right atrium to reduce pressure on the lungs and left side of the heart. (See “Corvia: Finally, an Intervention for the Other Half of Heart Failure,” MedTech Strategist, July 5, 2017.) In October 2019, the FDA granted Corvia Breakthrough Device designation for its Corvia Atrial Shunt. (Potential competitor V-Wave Ltd. also received the FDA’s Breakthrough Device designation in 2019, for its Ventura Interatrial Shunt. V-Wave is currently conducting its 400-patient pivotal trial, RELIEVE-HF.)