Coronary/Structural Heart

CathWorks FFRangio™ System Receives Regulatory Approval in Japan

KFAR-SABA, Israel and ALISO VIEJO, Calif., Dec. 11, 2019 /PRNewswire/ — CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW). The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images […]

Merit Medical launches PreludeSYNC EVO™ radial compression device in EMEA

Maastricht, The Netherlands – 11th December 2019 Merit Medical Systems Inc., a leading manufacturer of proprietary devices used primarily in cardiology, radiology, oncology, and endoscopy, announces the commercial launch of the PreludeSYNC EVO radial compression device in European, Middle Eastern and African markets. The product has FDA clearance in the […]

QuVa Pharma® Launches Cardioplegia Offering through a Compounding and Distribution Agreement with Hibernation Therapeutics for Adenocaine™ Solution

Access to improved Adenocaine™ solution, a ready to administer heart arrest and cardioprotection innovation, is immediately available to hospitals nationwide SUGAR LAND, Texas, Dec. 9, 2019 /PRNewswire/ — QuVa Pharma, Inc. today announced it has signed a production and distribution agreement with Hibernation Therapeutics for its patented cardioplegia solution Adenocaine™, the combination of […]

BioVentrix Announces Publication of Positive One-Year Outcomes for Revivent TC System

Study Published in European Journal of Heart Failure Shows Significant and Sustained Improvement in Heart Function, Symptom Relief and Quality of Life Using Less Invasive Left Ventricular Enhancement Device SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., developer of the first less invasive system for left ventricular remodeling, today announced online publication of positive […]

TransMedics’ Organ Care System (OCS™) Technology Used in First U.S. Adult Human Heart Transplants From DCD Donors

ANDOVER, Mass., Dec. 04, 2019 (GLOBE NEWSWIRE) — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced the completion of the first successful adult human heart transplants from DCD (donation after circulatory […]

Neovasc Named Finalist in Questex’s Fierce Innovation Awards LifeSciences Edition 2019

VANCOUVER, Dec. 04, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN): NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced today that it has been […]

Repairing children’s heart valves with patients’ own tissues at Stanford Children’s Health

Cardiac surgeons at Lucile Packard Children’s Hospital Stanford introduce the Ozaki procedure for pediatric patients STANFORD, Calif., Dec. 4, 2019 /PRNewswire/ — On Nov. 22, cardiothoracic surgeons at Lucile Packard Children’s Hospital Stanford began offering an innovative repair for children’s heart valves. The method, called the Ozaki procedure, involves crafting a new heart valve from the […]

CHF Solutions Announces Launch of Ultrafiltration Therapy Using Aquadex FlexFlow® System at Memphis Methodist Le Bonheur Healthcare System

EDEN PRAIRIE, Minn., Dec. 03, 2019 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced that Memphis, Tennessee-based health system, Methodist Le Bonheur, has initiated offering aquapheresis therapy to patients suffering from fluid overload using the company’s Aquadex FlexFlow system. The use of the therapy was featured in the Daily […]

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

WASHINGTON, Dec. 3, 2019 /PRNewswire/ — MCRA, LLC, a leading medical device advisory firm and Clinical Research Organization (CRO) that integrates regulatory, clinical research, reimbursement, compliance and quality assurance, is pleased to announce its role in the successful granting of a Breakthrough Device Designation for the CorFlow Therapeutics AG Controlled Flow Infusion (CoFITM) […]

Bracco Diagnostics Inc.’s LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use, receives U.S. Food and Drug Administration approval for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in pediatric patients with suboptimal echocardiograms

MONROE TOWNSHIP, N.J., Dec. 2, 2019 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world’s leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is the first ultrasound enhancing agent (UEA) to obtain U.S. Food and Drug Administration (FDA) approval for […]