PORTLAND, Ore., June 17, 2021 / PRNewswire / – VisCardia Inc., a private medical device developer, announced today that it has been selected to participate in MedTech Innovator’s annual demonstration and acceleration program. The screening process narrowed down 1,100 applicants from over 50 countries to 195 applicant companies who pitched their technology to teams of senior industry executives. From these 195 presentations, 50 companies (25 in initial phase and 25 in intermediate phase) were selected to participate in the MedTech conference organized by AdvaMed (AdvaMed) in September.

VisCardia’s advancement is based on its VisONE SDS® technology, which is an innovative approach to the treatment of advanced chronic heart failure. VisONE SDS completed a European First-in-Human study with very encouraging results which led to the granting of Revolutionary Device designation by the US FDA. The therapy uses a diaphragmatic pacemaker to modulate the pressure in the chest cavity and make it easier to fill and pump a weakened heart. The European study showed that patients’ heart performance improved, patients improved exercise tolerance, and patients felt better (improved quality of life) during a one-year trial.

Gregg Harris, Vice President of Clinical and Regulatory Affairs, said, “Through the Breakthrough Device program, we have entered into a collaborative relationship with the FDA to initiate clinical studies in the United States with the goal of making our technology available to consumers. American patients as quickly as possible. . “VisCardia plans to begin the study in early 2022 after recruiting the best medical centers in the country. The scientific advisory board is made up of leading cardiologists from three of the top 40 hospitals for heart failure according to US News & World rankings. Reports for 2020-2021.

Peter Bauer, Ph.D., CEO of VisCardia, said: “We are proud to see our presentations at international meetings, such as the MedTech conference powered by AdvaMed (Sep 27-29, 2021) and the Heart Failure Society of America (10-13 Sep 2021), gain the recognition and attention of scientific communities as well as industry leaders. We believe that our technology has an important role in the treatment of heart failure. “

About VisONE® SDS® Therapy

The VisONE Implantable System offers VisCardia’s proprietary Synchronized Diaphragmatic Stimulation (SDS) therapy to improve heart function in patients with heart failure. By electrically stimulating the diaphragm imperceptibly, transient intrathoracic pressures synchronized with cardiac activity are modulated, improving both cardiac filling and output. Therapy is non-invasively adjusted and scheduled using an external programmer to improve hemodynamic benefit and optimize stimulation parameters.

Media contact:
Gregg Harris
Telephone: 503-744-2375
E-mail: [email protected]

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VisCardia Inc.

SOURCE VisCardia Inc.