Medical devices maker VisCardia has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its implantable VisONE system to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony.
The FDA breakthrough device programme is a two-phase process, which is designed to support patients to secure timely access to breakthrough technologies.
VisCardia has completed the first phase of the programme for the system. The FDA will advance re-market reviews of VisCardia’s IDE(s) and the subsequent pre-market approval (PMA) application to request approval to commercialise the device in the US, during the second phase of the programme.
VisONE technology engages the diaphragm by employing stimuli synchronously with the cardiac cycle
VisONE technology is said to engage the diaphragm by employing stimuli synchronously with the cardiac cycle, helping to improve the blood flow via weak heart by modulating the pressures within the chest.
The VisONE implantable system provides the company’s synchronised diaphragmatic stimulation (SDS) therapy to improve cardiac function.
Transient intrathoracic pressures synchronised to cardiac activity are modulated by electrically stimulating the diaphragm in an imperceptible manner, helping to improve both cardiac filling and output.
VisCardia’s therapy is non-invasively adjusted and programmed with the support of an external programmer to enhance hemodynamic benefit and optimise stimulation parameters.
VisCardia CEO Dr Peter Bauer 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.”
In April 2019, VisCardia announced that it had completed the enrolment of patients and three month follow-up visits in its pilot study of VisONE implantable system.
