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BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

DAIC

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. The CardiAMP Heart Failure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers. said Peter Altman , PhD.,

CMS 111
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Procyrion Announces First Patient Enrollments in the DRAIN-HF Pivotal IDE Trial for Aortix Percutaneous Mechanical Circulatory Support Technology

DAIC

The DRAIN-HF study will evaluate the Aortix percutaneous mechanical circulatory support (pMCS) technology in patients with acute decompensated heart failure (ADHF) who are unresponsive to standard medical therapy. I am excited to be able to include the advanced heart failure patients in the trial," commented Dr. Grafton.