Coronary/Structural Heart

Abbott’s In-Development Fully Implantable Heart Pump System Earns FDA’s Breakthrough Device Designation

ABBOTT PARK, Ill., Feb. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Implantable Left Ventricular Assist System (FILVAS). The FDA launched the Breakthrough Devices Program in 2018 to help expedite the development and review […]

Medtronic Begins New Pilot Study as Part of SPYRAL HTN Clinical Program for Renal Denervation in Hypertension Patients

SPYRAL DYSTAL Study to Evaluate the Effects of RDN Using Fewer, Targeted Ablations to Achieve Meaningful Blood Pressure Reductions DUBLIN, Feb. 04, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity™ Spyral renal denervation (RDN) system […]

DILIsym Services Partners with Large Pharmaceutical Company to Begin QSP Model Development for Heart Failure

QSP Modeling Project Targeted at Prevention of Heart Failure RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–DILIsym Services Inc. (DSS), a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical efficacy and safety, today announced that it is developing a new component for a QSP model […]

Resverlogix Receives US FDA Breakthrough Therapy Designation for Apabetalone

CALGARY, Alberta, Feb. 03, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX) is pleased to announce the U.S. Food & Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for apabetalone in combination with top standard of care, including high-intensity statins, for the secondary prevention of major […]

Mesoblast Submits Completed Biologics License Application for Ryoncil™ to US FDA

NEW YORK, Feb. 03, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it has submitted its completed Biologics License Application (BLA) to the United States Food and Drug Administration (US FDA) for Ryoncil™ (remestemcel-L), its lead allogeneic cell therapy […]

Ancora Heart Announces Expansion of U.S. Early Feasibility Study

CorCinch HFrEF Study Evaluating Safety of AccuCinch Ventricular Repair System in Heart Failure Patients SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of enrollment in its CorCinch HFrEF […]

Neovasc Announces Renewal of German Reimbursement NUB Status 1 Designation for Neovasc Reducer for Treatment of Refractory Angina

VANCOUVER, Jan. 31, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: 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, today announced that the Institut für […]

Esperion Announces Positive CHMP Opinion for the Marketing Authorization Application for the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia

–  Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet is an Oral, Once-Daily, Non-Statin Medicine that Lowers Bad Cholesterol with a First-in-Class Mechanism  – –  Positive CHMP Opinion is Based on the Completed Pivotal Phase 3 Fixed Dose Combination Tablet LDL-Cholesterol Lowering Program  – –  European Commission Decision on the Marketing Authorisation Application […]

CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination tablet as treatments for hypercholesterolaemia

Bempedoic acid is an oral, once-daily ATP citrate lyase inhibitor that reduces cholesterol synthesis in the liver. This unique mechanism of action is complementary to statins and other lipid-lowering therapies1 Positive CHMP opinions are based on a global clinical trial programme demonstrating consistent LDL-C lowering across a range of patient […]

ABBOTT’S TENDYNE™ DEVICE RECEIVES WORLD’S FIRST CE MARK FOR TRANSCATHETER MITRAL VALVE IMPLANTATION

– First-of-its-kind technology addresses critical need to eliminate mitral regurgitation when surgery or mitral repair is not an option – Tendyne valve provides relief from heart failure symptoms and quality-of-life improvement in high-surgical-risk patients – Together with MitraClip™, Tendyne expands Abbott’s market-leading portfolio of innovative minimally invasive mitral valve solutions […]