Remove CMS Remove Heart Transplant Remove Outcomes
article thumbnail

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. We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study.” said Peter Altman , PhD.,

CMS 111
article thumbnail

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. The company recently announced it has received CMS approval for Medicare coverage during the DRAIN-HF pivotal trial.