Coronary/Structural Heart

Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation

SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ — Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH affects hundreds of thousands in the U.S. and globally and […]

Interim Analysis of Recardio’s Phase II Clinical Trial Published in European Heart Journal

Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced that its positive results of the interim analysis of Recardio’s Phase II clinical trial in AMI were published in the latest release of the European Heart Journal. The current version of the journal relates to the presentation […]

Small vessels can cause big problems; MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions

TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed […]

I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic

I Peace’s GMP-grade iPSCs are key to manufacture Avery Therapeutics’ MyCardia™, a proprietary tissue-engineered heart graft developed to treat heart failure TUCSON, Ariz. and PALO ALTO, Calif., Dec. 16, 2020 /PRNewswire/ — Avery Therapeutics, a Tucson-based company dedicated to advancing tissue-engineered therapeutics to treat diseases and injuries to human muscle, and I Peace, Inc., a Palo […]

BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Heart Failure Study as Designed

SAN CARLOS, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ Heart Failure Trial. The DSMB based its […]

Neovasc Announces Publication of Peer-Reviewed Article in EuroIntervention

REDUCER I Study Shows Improvement in Chest Pain Symptoms VANCOUVER and MINNEAPOLIS, Dec. 17, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that EuroIntervention, the official journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI), has published online a peer-reviewed study announcing […]

WhiteSwell Strengthens Patent Portfolio for Treatment of Acute Decompensated Heart Failure With Newly Issued U.S. Patent

Adds to Portfolio of 40 Patents for Catheter-Based Technology That Leverages Power of Body’s Natural Fluid Removal Process GALWAY, Ireland–(BUSINESS WIRE)–WhiteSwell, a company pioneering new ways to treat acute decompensated heart failure, announced today that the U.S. Patent and Trademark Office (USPTO) has granted the company a new patent for […]

Evidation Health, American College of Cardiology Announce Achievement for Heart Health, A Program to Help Individuals Monitor and Improve Cardiovascular Health

First-of-its-kind health engagement experience will deliver evidence-based content, resources, and tools to thousands of individuals experiencing heart failure SAN MATEO, Calif.–(BUSINESS WIRE)–Evidation Health and the American College of Cardiology (ACC) announced today they are joining forces to co-develop and launch Achievement for Heart Health–a health engagement experience built on Evidation’s Achievement platform–that will make […]

First-in-class cholesterol-lowering treatment NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet approved in Switzerland

– NILEMDO® (bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients – – Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies1,2 – […]

Corvion Receives Breakthrough Device Designation from FDA

WEBSTER, Texas, Dec. 16, 2020 /PRNewswire/ — Corvion – developer of fully implanted mechanical circulatory support devices – announced today that it has received Breakthrough Device Designation for its fully implanted Left Ventricular Assist Device (LVAD) from the FDA.  The designation will allow the company to interact with the FDA’s experts to […]