VisONE has now completed the first phase of the Breakthrough Devices Program by being designated to provide for more effective treatment of a life-threatening or irreversibly debilitating disease. During the second phase of the program, the FDA will expedite pre-market reviews of VisCardia’s IDE(s) as well as the subsequent Pre-Market Approval (PMA) application to request approval to commercialize the device in the U.S.
The VisONE technology 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, multi-center, pilot trial demonstrated that patients improved their quality of life, physical performance and hemodynamic 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 underserved patient population feel better and remain physically independent longer.
Peter Bauer, Ph.D., CEO of VisCardia, said, “As we continue to support scientific presentations at international meetings, this partnership with the FDA will expedite our entrance into the U.S. medical device market through the design and implementation of an initial IDE study. We are proud to have Dr. Lee Goldberg, section chief of the Advanced Heart Failure Program at the University of Pennsylvania, to serve as our U.S. principal investigator and Dr. 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.”