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CMS has reviewed the CardiAMP HeartFailure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. The CardiAMP HeartFailure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers. said Peter Altman , PhD.,
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.
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.
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).
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