VisCardia Completes Enrollment, Three-Month Follow-Up Visits for VisONE Heart Failure Pilot Study

VisCardia Inc., a privately held medical device developer, has completed enrollment and three month follow-up visits of the company’s VisONE implantable system pilot for medical refractory heart failure patients with reduced ejection fraction and preserved ventricular synchrony.
 
The VisONE Heart Failure pilot is a prospective open label, single arm, multi-center study conducted in select European countries to evaluate the safety of VisCardia’s novel VisONE implantable system for delivering Asymptomatic Diaphragmatic Stimulation (ADS) as a heart failure therapy.

“Our objectives are to demonstrate that the promising and consistent evidence of therapeutic efficacy observed to date with the VisONE implantable system can be delivered on a safe and chronic basis. We look forward to sharing our study results over the next upcoming months in peer reviewed scientific conferences,” said VisCardia’s Director of Medical Affairs, Dr. Michael Mirro. The primary measures of the study are safety of the minimally invasive laparoscopic surgical implant procedure and implanted system, with secondary endpoints of heart failure therapeutic efficacy, including acute hemodynamic parameters, cardiac function and heart failure status.
 
“VisONE provides an innovative and unique approach for improving cardiac performance in medical refractory heart failure patients who currently have no alternative treatment options,” said Dr. Michel Zuber, the principal investigator at the University Hospital in Zurich, Switzerland. “Our expectations are that the chronic improvements to clinically accepted endpoints will mirror those observed during our early proof of concept studies.”

The VisONE implantable system delivers VisCardia’s proprietary ADS therapy for improving cardiac function. By electrically stimulating the diaphragm in an asymptomatic manner, transient intrathoracic pressures gaited to cardiac activity are applied against the cardiac walls, improving both cardiac filling and output. The therapy is non-invasively adjusted and programmed using an external programmer to improve hemodynamic benefit and eliminate undesired stimulatory side effects.
 
Dr. Tamaz Shaburishvili, from the Heart & Vascular Clinic in Tbilisi, Georgia, one of the study centers, stated that, “While patient enrollment is an accomplishment in any clinical study, we believe the rapid enrollment rate for VisONE can be attributed to the promising evidence to date, the minimally invasive implant procedure, combined with the lack of options for these patients in our center.”
 
VisCardia, based in Portland, Oreg., is developing an implantable device therapy for treating heart failure, a condition that afflicts 10 million patients in the United States and Europe.