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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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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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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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CVRx Announces Key Senior Leadership Team Hires

DAIC

Adamson, MD, MSc, FACC, FESC, FRCP (Ed ) has been appointed as Chief Medical Officer, Bonnie Handke, RN, MBA will assume the role of Senior Vice President of Patient Access, Reimbursement, and Healthcare Economics, and Jennifer E. Englund recently joined as Senior Vice President of Global Clinical Affairs. Handke earned an MBA from St.

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Single/Dual Chamber vs. Cardiac Resynchronization Pacemakers for Cardiac Resynchronization – Results from the SYNCHRONY Collaborative Group

HeartRhythm

In patients with heart failure (HF) undergoing left bundle branch area pacing (LBBAP) for cardiac resynchronization therapy (CRT) without a defibrillator (e.g., However, in some countries CRT is not reimbursed if a 3-lead device is not used, and the clinical impact of avoiding this additional lead has not been established.

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American College of Cardiology, ACC, Releases Guide to Remote Patient Management

DAIC

In its announcement about the workbook, ACC noted that cardiologists use digital devices and wearable technology to remotely monitor their patients for a variety of chronic cardiovascular diseases, including heart failure, coronary artery disease, vascular disease and atrial fibrillation. Food and Drug Administration authorization.

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Cardiac Dimensions Appoints Satya Shreenivas, MD, as Chief Medical Officer

DAIC

There, he served as an investigator in many high-profile clinical trials, including several significant structural heart studies. Dr. Shreenivas is a frequent speaker at major scientific meetings and has been widely published in peer-reviewed journals across the structural heart, heart failure, and coronary arenas.