FDA Breakthrough Device Designation Granted for Alleviant Medical’s Technology to Treat Chronic Heart Failure

January 25, 2021—Alleviant Medical Inc. announced that the FDA has granted Breakthrough Device designation for the company’s transcatheter technology, which offers a no-implant interatrial shunt therapy for patients with heart failure (HF) with preserved ejection fraction (HFpEF) and midrange ejection fraction (HFmrEF) who remain symptomatic despite optimal guideline-directed medical therapy.

In the company’s announcement, Chief Medical Officer and Cofounder Jacob Kriegel, MD, commented, “Current pharmaceutical options for treating HFpEF/HFmrEF are limited, and patients stand to benefit from additional innovative device therapies. Our technology enables the creation of a therapeutic interatrial shunt, intended to offload elevated left atrial pressure in properly indicated HFpEF/HFmrEF patients, without the need for a permanent cardiac implant. We are currently developing robust clinical evidence through investigational use of this novel therapy and look forward to reporting outcomes from our initial patient series later this year.”

The Alleviant Medical technology is under investigational use only and is not available for commercial distribution in the United States or any other market, advised the company.

The FDA Breakthrough Device program creates a pathway for patients to have more timely access to innovative medical devices by expediting their development, assessment, and review while preserving the statutory standards for premarket approval.