Remove CMS Remove Heart Failure Remove Quality of Life
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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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Patient Enrollment Commenced in Pivotal Phase 3 Trial of CardiAMP Cell Therapy for the Treatment of Ischemic Heart Failure

DAIC

BioCardia previously confirmed alignment with the United States Food and Drug Administration (FDA) on the design of the 250-patient randomized, controlled trial and the minimum of 12-month primary composite endpoint of all cause death, reduction in major adverse cardiovascular events, and improvement in quality of life.

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BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes

DAIC

Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients.

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From the Member Sections | Tackling the Polypharmacy Pandemic in CV Care

American College of Cardiology

Initiatives such as the World Health Organization's "Medication Without Harm" and the Centers for Medicare and Medicaid Services' (CMS) expanded quality measures aim to reduce preventable emergency visits and hospital admissions due to medication-related harm. had one or more severe potential drug-drug interaction.1 BMC Med2015;13(74).