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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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CMS to cover implantable heart failure device

Becker's Hospital Review - Cardiology

"CMS proposes Medicare and Medicaid coverage for implantable pulmonary artery pressure sensors to manage heart failure. Final decision to be published on Jan.

CMS 52
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Patient Enrollment Commenced in Pivotal Phase 3 Trial of CardiAMP Cell Therapy for the Treatment of Ischemic Heart Failure

DAIC

FDA granted CardiAMP Cell Therapy a Breakthrough Device Designation for the treatment of ischemic heart failure. Leslie Miller, MD , trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida and a member of the CardiAMP Heart Failure II Study Executive Steering Committee. “As

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Biocardia Reports Positive Interim Results from Phase III Cardiamp Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

DAIC

Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (2.9%

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

DAIC

About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy for Ischemic Heart Failure, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response.

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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. BMC Med2015;13(74). Page RL 2nd, O'Bryant CL, Cheng D, et al. Circulation.

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Abstract 280: Risk Factors in 90day Ischemic Stroke Readmissions

Stroke: Vascular and Interventional Neurology

Factors considered in analysis include patient age, sex, geographic region, Medicaid dual eligibility, disability status prior to age 65, comorbidities, admission length of stay, discharge disposition, and hospital characteristics. 1.378]), and heart failure (1.282 [95%CI, 1.25‐1.315]).ConclusionPatient