VisCardia Announces Publication of RECOVER-HF Pilot Trial in JACC: Heart Failure

Publication marks a milestone for VisONE™ cardiac diaphragm support as enrollment continues in the RECOVER-HF pivotal IDE trial

PORTLAND, Ore., Oct. 22, 2026 (GLOBE NEWSWIRE) -- VisCardia, Inc. today announced the publication of results from the RECOVER-HF pilot trial in JACC: Heart Failure. The study is the first randomized, double-blinded, sham-controlled evaluation of the company’s investigational VisONE™ Synchronized Diaphragmatic Stimulation (SDS) Therapy, also known as cardiac diaphragm support, in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

VisONE delivers precisely timed electrical stimulation to a small region of the left hemi-diaphragm in synchrony with the cardiac cycle. Implanted using a minimally invasive, two-port laparoscopic approach, the system places no hardware in or on the heart. The therapy has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

“Patients who remain symptomatic despite guideline-directed medical therapy need additional treatment options,” said Marat Fudim, MD, MHS, of Duke University School of Medicine and first author of the publication. “Cardiac diaphragm support is a distinct approach, and this sham-controlled pilot provides an important foundation for evaluating its potential.”

The 35-patient pilot was designed to establish the feasibility of blinded, sham-controlled evaluation of an implanted therapy and to inform the design of a pivotal trial. Its findings shaped the endpoints and design of the ongoing RECOVER-HF pivotal trial. 

“The RECOVER-HF pivotal trial is designed to provide a definitive assessment of SDS and its potential to improve the lives of patients with heart failure,” said Lee R. Goldberg, MD, MPH, of the University of Pennsylvania Perelman School of Medicine and national principal investigator of RECOVER-HF. “The pilot has helped us shape that evaluation, which is now underway at centers in the United States and internationally.”

“Publication in JACC: Heart Failure is an important milestone for VisCardia and the clinical development of cardiac diaphragm support,” said Peter Bauer, Ph.D., President & CEO of VisCardia. “Our focus is on advancing a minimally invasive approach that may expand treatment options for people living with heart failure. We are encouraged by the interest from investigators and centers joining RECOVER-HF. We are grateful to the patients, investigators, and clinical teams whose commitment has made this work possible.”

The article is available open access in JACC: Heart Failure. DOI: 10.1016/j.jchf.2026.103414.

About the RECOVER-HF Pivotal Trial

RECOVER-HF (NCT06552637) is a prospective, multi-center, double-blinded, sham-controlled, randomized clinical trial evaluating VisONE Synchronized Diaphragmatic Stimulation Therapy in patients with symptomatic HFrEF. Eligible patients have NYHA Class II or III heart failure, left ventricular ejection fraction of 40% or less, are not candidates for cardiac resynchronization therapy (CRT), and are on optimized guideline-directed medical therapy. Primary endpoints include freedom from device and procedure related events, change in left ventricular end-systolic volume, six-minute walk distance, and quality of life. The trial is actively enrolling at well recognized sites across the United States and internationally.

About VisCardia, Inc.

VisCardia, Inc. is a privately held medical device company based in Portland, Oregon, dedicated to developing minimally invasive therapies for the millions of patients living with heart failure. The company's VisONE Synchronized Diaphragmatic Stimulation Therapy, also known as cardiac diaphragm support, has been granted Breakthrough Device Designation by the U.S. FDA and is currently being evaluated in the RECOVER-HF pivotal IDE trial, enrolling at up to 30 sites, as the company advances toward PMA submission. For more information, visit viscardia.com.

Media Contact:
Jennifer Matson
matsonj@viscardia.com