VisCardia Marks First-of-Its-Kind U.S. Implantation in RECOVER-HF Trial

VisCardia has announced the implantation of the first US patient in its RECOVER-HF pivotal trial evaluating VisONE Synchronized Diaphragmatic Stimulation 

Therapy, an investigational approach for patients with symptomatic heart failure with reduced ejection fraction. The therapy has received Breakthrough Device Designation from the US Food and Drug Administration.

The procedure was carried out at the University of Pennsylvania as part of the multi-centre clinical study. 

RECOVER-HF is assessing whether synchronised electrical stimulation of the diaphragm can support cardiac function in patients who continue to experience symptoms despite guideline-directed medical therapy.

VisONE is a minimally invasive implantable system designed to deliver timed electrical stimulation to a small area of the left side of the diaphragm in coordination with the cardiac cycle. 

The system is implanted laparoscopically using a two-port technique and does not place hardware directly in or on the heart.

The RECOVER-HF trial is a prospective, randomised, double-blinded and sham-controlled study involving patients with NYHA Class II or III heart failure, a left ventricular ejection fraction of 40 per cent or less, and QRS duration of 130 milliseconds or less. 

The study will assess cardiac function, walking capacity, quality of life and safety.