Released by Newswire.com
PORTLAND, Ore. – VisCardia Inc., a privately held medical device developer, announced today it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its implantable VisONE® system designed for the treatment of moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony.
The FDA Breakthrough Device Program is a two-phase process intended to help patients receive more timely access to breakthrough technologies. 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.
Gregg Harris, VP of Clinical & Regulatory Affairs, stated, “We are very excited that the FDA recognizes the great potential for this novel therapy and are looking forward to a productive collaboration with the FDA to ensure this technology can begin improving patients’ lives as soon as possible.”
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.”
About VisONE®SDS Therapy
The VisONE implantable system delivers VisCardia’s proprietary Synchronized Diaphragmatic Stimulation (SDS) therapy for improving cardiac function. By electrically stimulating the diaphragm in an imperceptible manner, transient intrathoracic pressures synchronized to cardiac activity are modulated, improving both cardiac filling and output. The therapy is non-invasively adjusted and programmed using an external programmer to improve hemodynamic benefit and optimize stimulation parameters.