VisCardia has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its implantable VisONE system, which is designed for the treatment of moderate-to-severe heart failure with reduced ejection fraction and preserved ventricular synchrony. A press release reports that VisONE has now completed the first phase of the Breakthrough Devices programme by being designated to provide for more effective treatment of a life-threatening or irreversibly debilitating disease.
During the second phase of the programme, the FDA will expedite premarket reviews of VisCardia’s IDE(s) as well as the subsequent premarket approval (PMA) application to request approval to commercialise the device in the USA. The FDA Breakthrough Device Program is a two-phase process intended to help patients receive more timely access to breakthrough technologies.
The VisONE technology, according to the press release, recruits the diaphragm by applying stimuli synchronously with the cardiac cycle which improves the blood flow through a weak heart by modulating the pressures within the chest. A recent European, multicentre, pilot trial demonstrated that patients improved their quality of life, physical performance and haemodynamic measurements when implanted with a VisONE device and followed for one year. VisCardia believes that expanding the size of the patient population studied to date will further illustrate the clinical benefit of this technology and lead to a minimally invasive therapy that will make this under-served patient population feel better and remain physically independent longer.
Peter Bauer, CEO of VisCardia, comments: “As we continue to support scientific presentations at international meetings, this partnership with the FDA will expedite our entrance into the US medical device market through the design and implementation of an initial IDE study. We are proud to have Lee Goldberg, section chief of the Advanced Heart Failure Program at the University of Pennsylvania, to serve as our US principal investigator and Michael Mirro, chief academic research officer at Parkview Health and Clinical Professor of Medicine at Indiana University, as our medical director to assist us in identifying future clinical sites and implementing the next phase of our clinical research.”