Coronary/Structural Heart

Corvia Medical Announces Enrollment of First Patients in Pivotal Trial of the IASD System II for the Treatment of Heart Failure

ANAHEIM, Calif., Nov. 14, 2017 /PRNewswire/ — Corvia Medical, Inc., a privately-held medical device company that developed a first-in-class transcatheter structural heart device to treat heart failure, today announced that it has enrolled the first patients in its global multicenter trial (REDUCE LAP-HF II) of the Interatrial Shunt Device (IASD) […]

Plaxgen Plaque Array Lipid-Modifying Drugs Study Published in Journal of Visualized Experiments

FREMONT, Calif., Nov. 13, 2017 /PRNewswire/ — Plaxgen Inc,developing flow cytometry-based blood diagnostics for plaque-associated diseases, such as atherosclerosis and Alzheimer’s, announced that new research exploring the effect of lipid-lowering drugs, including statins, on the morphology of cholesterol particles in human serum samples was published in the peer-reviewed journal, “Journal of […]

Cambridge’s PlaqueTec Names Former Dimension Therapeutics CEO as New Leader

CAMBRIDGE, England, November 13, 2017 /PRNewswire/ — The Board of Directors of PLAQUETEC LTD (‘PlaqueTec’) today announced the appointment of Annalisa Jenkins, MBBS, FRCP, as the company’s Chief Executive Officer.  Dr. Jenkins, most recently CEO of U.S.-based Dimension Therapeutics, will lead the 2018 launch of the pioneering biomarker-based PlaqueTec Liquid Biopsy System(TM) […]

SentreHEART Announces Participation at American Heart Association Scientific Sessions 2017

REDWOOD CITY, Calif.–(BUSINESS WIRE)– SentreHEART, Inc., the manufacturer of the LARIAT® Suture Delivery Device (LARIAT) will be participating in the American Heart Association (AHA) Scientific Sessions 2017 in Anaheim, California November 11-15, 2017. AHA’s Scientific Sessions attracts nearly 18,000 attendees, with a global presence from more than 100 countries. With a commitment to […]

CryoLife Announces Enrollment of First Patients in BioGlue Clinical Trial in China

ATLANTA, Nov. 6, 2017 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY),a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that enrollment has started in the Company’s BioGlue clinical trial in China. The results from the trial will serve as the basis of the Company’s regulatory submission […]

HeartFlow Announces Decision by Centers for Medicare & Medicaid Services to Assign a New Technology Payment Classification to HeartFlow® FFRct Analysis

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that the Centers for Medicare & Medicaid Services (CMS) has finalized a New Technology Ambulatory Payment Classification (APC) for the HeartFlow® FFRct Analysis, a first-of-its-kind non-invasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). Under the APC payment system, […]

ABBOTT’S MITRACLIP APPROVED AS FIRST TRANSCATHETER MITRAL VALVE REPAIR DEVICE IN JAPAN

ABBOTT PARK, Ill., Nov. 6, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the company’s MitraClip device for treatment of people with mitral regurgitation (MR), a serious, progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward […]

Neovasc Jumps on FDA Nod for Clinical Trial

VANCOUVER, Nov. 6, 2017 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company“) (NASDAQ, TSX: NVCN) announced that it has received approval of the U.S. Food and Drug Administration (“FDA”) to initiate the COSIRA-II IDE pivotal clinical trial.  The trial’s purpose will be to demonstrate the safety and effectiveness of the Company’s novel Reducer system […]