Coronary/Structural Heart

LivaNova Receives FDA Clearance for 3T Heater-Cooler Device Modification

LONDON–(BUSINESS WIRE)–Feb. 25, 2020– LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for a device modification to its 3T Heater-Cooler® devices. The modification includes the installation of a 3T Aerosol Collection Set, as well as testing that demonstrates the effectiveness of […]

CHF Solutions receives 510(k) clearance for Aquadex SmartFlow™ system in Pediatric Patients Weighing 20kg or More

EDEN PRAIRIE, Minn., Feb. 26, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced FDA 510(k) clearance in the U.S. of its next generation Aquadex SmartFlow console for use in adult and pediatric patients who weigh 20kg or more. The console is a simple, gentle, and smart solution for treatment of patients suffering from hypervolemia […]

Neurimmune Announces the Initiation of a Phase 1 Study of NI006 for the Treatment of ATTR Cardiomyopathy

ZURICH, Feb. 27, 2020 /PRNewswire/ — Neurimmune AG, the discoverer of aducanumab and cinpanemab, announced today enrollment of the first patient in a Phase 1 clinical trial to evaluate NI006 in transthyretin amyloid cardiomyopathy (ATTR cardiomyopathy). NI006 is a human antibody directed against transthyretin amyloid (TTR amyloid) consisting of misfolded and aggregated […]

BIOLIFE4D CSO Dr. Ravi Birla Publishes Paper in Prestigious APL Bioengineering Scholarly Journal

Birla co-published paper with Stuart K. Williams, a renowned industry figure, to highlight 3D bioprinting’s impact on cardiac failure treatment CHICAGO, Feb. 27, 2020 (GLOBE NEWSWIRE) — BIOLIFE4D, a biotech pioneer leveraging advances in tissue engineering to 3D print human organs viable for transplant, today announced its Chief Science Officer, Dr. […]

Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

– NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins – – First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved – – Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, […]

Otitopic Advances Asprihale® Into Pivotal PK/PD Study

Asprihale® is intended for emergency treatment to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI). LOS ANGELES–(BUSINESS WIRE)–Otitopic today announces that it is advancing towards its pivotal PK/PD study following discussions with the FDA. The randomized pivotal study, which is expected to initiate in the […]

Amgen, Cytokinetics And Servier Announce Continuation Of GALACTIC-HF Following Planned Interim Analysis

Data Monitoring Committee Recommends Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Heart Failure Continue without Changes Topline Results Expected in Q4 2020 THOUSAND OAKS, Calif., SOUTH SAN FRANCISCO, Calif., and SURESNES, France, Feb. 26, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and Servier today announced that the Data Monitoring Committee (DMC) […]

Foldax Tria LifePolymer Heart Valve Technology Honored with Best Innovation Award at 2020 Cardiovascular Research Technologies Meeting

SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that Tria LifePolymer™ heart valve technology was honored with The Best Innovation Award at the 2020 Cardiovascular Research Technologies (CRT) meeting in National Harbor, MD. The presentation, titled “Foldax Tria First in Human Implant of a Totally Synthetic Polymeric Aortic Heart Valve,” was given […]

PhysIQ and U.S. Veteran’s Affairs Publish Breakthrough Study Predicting Heart Failure Hospitalization up to 10 days in Advance using AI

PhysIQ and the U.S. VA publish results of a clinical trial that demonstrates how artificial intelligence (AI) applied to continuous wearable sensor data may predict hospitalizations. When coupled with the high sensor wear compliance rates, the 7-10-day early warning timeframe suggests this approach has great promise to reduce hospitalization and […]

New Data Confirms Cardiac Dimensions’ Carillon® System Shows Favorable Long-Term Survival Rate In Patients With Functional Mitral Regurgitation

Pooled Analysis of Prospective Studies Presented during Late Breaking Trials Session at CRT 2020 KIRKLAND, Wash., Feb. 25, 2020 /PRNewswire/ — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the findings of a post hoc analysis of […]