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Portland, Oregon., June 17, 2021 /PRNewswire/ – Viskadia, A privately held medical device developer, announced today that it has been selected to participate in MedTech Innovator’s annual showcase and accelerator program. The selection process reduced 1,100 applicants from more than 50 countries to 195 candidate companies that demonstrated their skills to senior industry leadership teams. From these 195 speeches, 50 companies (25 early and 25 mid-term) were selected to participate in the MedTech conference supported by the Advanced Medical Technology Association (AdvaMed) in September.
VisCardia’s advancement is based on its VisONE SDS® technology, an innovative treatment for advanced chronic heart failure. VisONE SDS has completed a European first human study, and the results are very encouraging, leading the US FDA to grant a breakthrough device designation. The therapy uses a diaphragm stimulator to regulate the pressure in the chest cavity, making it easier for a weak heart to fill and pump blood. This European study showed that in a one-year trial, patients’ heart function improved, patients’ exercise endurance improved, and patients felt better (improved quality of life).
Greg HarrisThe vice president of clinical and regulatory affairs said, “Through the breakthrough device program, we have begun to establish a cooperative relationship with the FDA and start clinical research in the United States. The goal is to provide our technology to American patients as soon as possible.” VisCardia plans to recruit The country’s top medical center will start the study in early 2022. The Scientific Advisory Board is composed of leading cardiologists from three of the top 40 heart failure hospitals in 2020-2021 by U.S. News and World Report.
Peter BallVisCardia CEO, Ph.D. said: “We are proud to see our presentations at international conferences, such as the MedTech conference supported by AdvaMed (September 27-29, 2021) And the American Heart Failure Association (September 10-13, 2021), gaining recognition and attention from leaders in the scientific community and industry. We believe that our technology plays an important role in the treatment of heart failure. “
About VisONE® Safety Data Sheet® treatment
The VisONE implantable system provides VisCardia’s proprietary Synchronous Diaphragm Stimulation (SDS) therapy to improve heart function in patients with heart failure. By electrically stimulating the diaphragm in an imperceptible way, the instantaneous intrathoracic pressure synchronized with heart activity is adjusted, thereby improving cardiac filling and output. The therapy uses an external programmer for non-invasive adjustment and programming to improve hemodynamic benefits and optimize stimulation parameters.
Media Contact:
Greg Harris
Phone: 503-744-2375
e-mail: harrisg@viscardia.com
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Viskadia
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SOURCE VisCardia Inc.
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