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CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. Across all patients there was a reduction in cardiac death equivalents and major adverse cardiac and cerebrovascular events.
The primary effectiveness endpoint was a composite of death, hearttransplant/left ventricular assist device (LVAD) implantation, HF hospitalization, outpatient HF worsening, and quality of life. and worldwide," said Neal Eigler, M.D. , CEO of V-Wave.
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