Coronary/Structural Heart

B. Braun Interventional Systems Expands its Congenital and Structural Heart Portfolio With the EmeryGlide™ MR Conditional Guidewire From Nano4Imaging

BETHLEHEM, Pa., Aug. 29, 2019 (GLOBE NEWSWIRE) — B. Braun Interventional Systems Inc. (BIS), a company dedicated to providing innovative solutions in the field of congenital and structural interventional cardiology, today announced it has signed an exclusive U.S. distribution agreement with Nano4imaging for their EmeryGlide™ guidewire. The EmeryGlide MR conditional […]

FDA Grants Fast Track Designation for Farxiga in Chronic Kidney Disease

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD). The FDA’s Fast Track program is designed […]

New study to investigate impact of proactive-voice caregiving for heart failure patients announced

BOSTON, Aug. 27, 2019 (GLOBE NEWSWIRE) — LifePod® Solutions Inc., the groundbreaking, proactive-voice caregiving service, has joined the American Heart Association’s Center for Health Technology & Innovation (the Center) Innovators Network to implement a first-of-its-kind heart failure study to support CarePlan adherence among those suffering from chronic heart conditions. The Center is focused […]

Amarin Provides Overview on Growing Global Attention on REDUCE-IT™ Results and Cardiovascular Risk Management Beyond Cholesterol Management

Multiple Papers and Presentations Highlight REDUCE-IT and Vascepa® Potential Mechanisms of Action of Vascepa Becoming Better Understood American Heart Association References REDUCE-IT in Scientific Advisory BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 27, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today provided […]

Miracor Medical Granted FDA Breakthrough Device Designation for the PiCSO Impulse System

AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases […]

MyoKardia Begins Dosing in Phase 1 Clinical Study of MYK-224 for Hypertrophic Cardiomyopathy

SOUTH SAN FRANCISCO, Calif., Aug. 21, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced that it has dosed the first subjects in a Phase 1 clinical study of MYK-224, a small molecule candidate being developed for the treatment of hypertrophic cardiomyopathy (HCM). HCM is a progressive disease in which […]

FARXIGA Met Primary Endpoint in Landmark Phase III DAPA-HF Trial for the Treatment of Patients With Heart Failure

DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor in patients with and without type 2 diabetes FARXIGA significantly reduced the risk of cardiovascular death or worsening of heart failure when added to standard of care WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive results from the landmark Phase […]

Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality

DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is […]

Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients

IRVINE, Calif., Aug. 16, 2019 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems to the treatment […]

MyoKardia Launches 2nd Annual MyoSeeds™ Research Grants Program to Advance Independent Research in Heart Disease

Pre-Application Letters of Intent are Due September 13 for the 2019-2020 Funding Cycle SOUTH SAN FRANCISCO, Calif., Aug. 15, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. today announced the launch of the 2nd Annual MyoSeeds™ Research Grants Program, an initiative to support original, independent research in the biology and underlying mechanisms of cardiomyopathies […]