Portland, Oregon–based VisCardia designed its VisOne system to provide synchronized diaphragmatic stimulation (SDS) therapy — also known as cardiac diaphragm support. It aims to provide therapy for symptomatic heart failure with reduced ejection fraction (HFrEF).
VisOne, a minimally invasive, implantable system delivers precisely timed electrical stimulation to a small region of the left hemidiaphragm in synchrony with the cardiac cycle. Implantation takes place laparoscopically through a two-port technique and requires no hardware placed on in or on the heart. This means patients remain candidates for any future device therapy they may require. That can include cardiac resynchronization therapy and implantable defibrillators.
Dr. Jarrod Predina performed the first implant at the University of Pennsylvania in collaboration with Dr. Lee R. Goldberg. Goldberg serves as the national principal investigator of RECOVER-HF.
RECOVER-HF evaluates VisOne in patients with NYHA Class II or III heart failure, left ventricular ejection fraction of 40% or less, QRS duration of 130 ms or less, and are on guideline-directed medical therapy. Primary endpoints include change in left ventricular end-systolic volume, six-minute walk distance, quality of life, and safety.
VisCardia has enrollment underway at sites across the U.S. and at international centers.
Commentary from VisCardia leadership and investigators
Peter Bauer, president and CEO of VisCardia, said:
“The first U.S. implant marks a significant milestone for VisCardia and the RECOVER-HF trial, more importantly, for the patients with symptomatic heart failure who continue to need better options. RECOVER-HF is the pivotal evaluation that VisONE Synchronized Diaphragmatic Stimulation Therapy deserves, and we’re grateful to Dr. Goldberg and the entire trial team for their leadership in advancing it.”
Dr. Goldberg added:
“VisONE represents a promising and intuitive therapy for the substantial population of heart failure patients who continue to struggle despite optimized medical therapy. By leveraging the diaphragm’s natural physiologic contribution to cardiac function, VisONE supports the heart without placing any hardware in or on it. RECOVER-HF is designed to rigorously evaluate whether this approach can benefit patients with symptomatic HFrEF.”
