VisONE heart failure pilot study : Oregon-based medical device developer VisCardia has wrapped up its first-in-human study of the implantable VisONE system for medically refractory heart failure patients who have reduced ejection fraction (HFrEF) and preserved ventricular synchrony.
The VisONE Heart Failure pilot trial was a prospective, open-label, multi-center study held at certain European Heart Centers to assess the safety of VisCardia’s VisONE system for delivering asymptomatic diaphragmatic stimulation (ADS) as a treatment for heart failure.
The primary measures of the VisONE heart failure pilot study were the safety of the minimally invasive, surgical implant procedure and implanted system while gathering observational data on the heart failure status of patients, including acute hemodynamic parameters, exercise tolerance, cardiac function, and Quality-of-Life.
Peter Bauer – CEO of VisCardia said: “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.”
The VisONE system by delivering VisCardia’s asymptomatic diaphragmatic stimulation therapy aims to enhance cardiac function. Through electrical stimulation of the diaphragm in an asymptomatic manner, transient intrathoracic pressures, synchronized to cardiac activity, are regulated, thereby boosting cardiac filling and also output.
According to VisCardia, the therapy can be streamlined using an external programmer to improve hemodynamic benefit and also optimize stimulation parameters.