VisCardia Announces Completion of Its VisONE Heart Failure Pilot Study
PORTLAND, Ore., March 9, 2020 /PRNewswire/ -- VisCardia Inc., a privately held medical device developer, announced today it has completed the company's First-in-Human study of the implantable VisONE® system for medically refractory heart failure (HF) patients with reduced ejection fraction (HFrEF) and preserved ventricular synchrony.
The VisONE Heart Failure pilot was a prospective, open-label, multi-center study conducted in select European Heart Centers to evaluate the safety of VisCardia's VisONE system for delivering Asymptomatic Diaphragmatic Stimulation (ADS) as an innovative treatment for HF. The primary measures of the study were safety of the minimally invasive, surgical implant procedure and implanted system while collecting observational data on the patients' HF status, including acute hemodynamic parameters, cardiac function, exercise tolerance and Quality-of-Life. "Our objectives were to demonstrate that the VisONE implantable therapy can be delivered on a safe and chronic basis, and the improvements to clinically significant endpoints corroborate those observed during our early proof-of-concept studies. Those objectives were met, and the investigators will share the promising results through publications in peer-reviewed journals and conferences in the coming months," said Prof. Dr. Michel Zuber, University Hospital in Zurich, Switzerland, representing the study's scientific advisory committee.
"VisONE provides an innovative and unique approach for improving cardiac performance in chronic HF patients, whose only current treatment options include specialized surgical techniques performed by a very limited number of physicians. The findings in our VisONE Heart Failure pilot study not only confirm the encouraging results that we have seen in previous proof-of-concept studies, but they pave the way to move the technology into U.S. clinical studies and demonstrate these clinical benefits on a larger patient cohort," said VisCardia's Director of Medical Affairs, Dr. Michael Mirro.
Dr. Lee Goldberg, Section Chief of the Advanced Heart Failure Program at the University of Pennsylvania, USA, stated that "Based on the promising evidence to date, the minimally invasive implant procedure, and the limited options available for these patients, I am excited to see the technology enter U.S. clinical trials and to serve as the U.S. Principal Investigator for VisCardia's upcoming U.S. clinical trial."
Peter Bauer, Ph.D., CEO of VisCardia and a physicist with extensive experience in the medical device industry, states, "VisONE ADS technology recruits systemic control of intrathoracic pressure by the diaphragm to create a type of natural circulatory assist that allows the weakened heart to pump more efficiently. While other technologies attempt to encourage the weakened heart to work harder, we are making it easier for the weak heart to work better."
About VisONE® ADS Therapy
The VisONE system delivers VisCardia's proprietary Asymptomatic Diaphragmatic Stimulation therapy to improve cardiac function. By electrically stimulating the diaphragm in an asymptomatic manner, transient intrathoracic pressures, synchronized to cardiac activity, are modulated, improving both cardiac filling and output. The therapy can be optimized using an external programmer to improve hemodynamic benefit and optimize stimulation parameters.
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