VisCardia Announces Publication of Cardiac Diaphragm Support Pilot Trial
News related to:VisCardia, Inc · 1 min read
PORTLAND, Ore., Oct. 22, 2026 /CourierPR/ -- VisCardia, Inc., a privately held medical device company based in Portland, Oregon, has announced the publication of results from the RECOVER-HF pilot trial in JACC: Heart Failure. The study marks 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).
The VisONE™ therapy 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).
Cardiac diaphragm support is a distinct approach, and the sham-controlled pilot provides an important foundation for evaluating its potential.
The 35-patient pilot was designed to establish the feasibility of a blinded, sham-controlled evaluation of an implanted therapy and to inform the design of a pivotal trial. Its findings have shaped the endpoints and design of the ongoing RECOVER-HF pivotal trial, which is evaluating VisONE Synchronized Diaphragmatic Stimulation Therapy in patients with symptomatic HFrEF.
RECOVER-HF (NCT06552637) is a prospective, multi-center, double-blinded, sham-controlled, randomized clinical trial. Eligible patients have NYHA Class II or III heart failure, a 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.
The publication of the RECOVER-HF pilot trial in JACC: Heart Failure is an important milestone for VisCardia and the clinical development of cardiac diaphragm support.
The article is available open access in JACC: Heart Failure. DOI: 10.1016/j.jchf.2026.103414.