VisCardia has developed a unique implantable system ‘VisONE® system’ to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony.
By applying stimuli synchronously with the cardiac cycle, the VisONE technology engages the diaphragm, helping to enhance blood flow via a weak heart by modulating the pressures within the chest.
VisCardia’s proprietary Synchronized Diaphragmatic Stimulation (SDS) therapy for improving cardiac function is delivered by VisONE implantable system. The transient intrathoracic pressures gaited to cardiac activity are modulated, improving both cardiac filling and output, by electrically stimulating the diaphragm in an undetectable manner.
To improve hemodynamic benefit and eliminate undesired stimulatory side effects, the therapy is non-invasively adjusted and programmed using an external programmer. The FDA Breakthrough Device Programme is a two-phase process, which is meant to support patients to secure timely access to breakthrough technologies.
The first phase of the programme for the system has been completed by being designated to provide for more effective treatment of a life-threatening or irreversibly debilitating disease. The FDA, during the second phase of the programme, will advance pre-market reviews of VisCardia’s IDE (s) and therefore the subsequentPre-market Approval (PMA) application to request approval to commercialise the device in the US.
A recent pilot trialin patients showed that there has been an improvement in the quality of life, physical performance, and hemodynamic measurements when implanted with a VisONE device and followed for a year.