Coronary/Structural Heart

Stealth BioTherapeutics Presents Positive Elamipretide Data in Pediatric Cardiology at International Society for Heart Research North American Section Meeting 2021

Elamipretide data demonstrated improvement in mitochondrial function in pediatric cardiomyopathy BOSTON, Sept. 28, 2021 /PRNewswire/ — Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today the presentation of positive elamipretide data showing improvements in mitochondrial respiration […]

Zebra Medical Vision Secures 8th FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

This latest milestone helps Zebra-Med expand its mission of screening populations at scale with its AI-based solutions, promoting early and preventative healthcare treatment. The CAC solution analyzes already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with […]

New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events

Pivotal UNIVERSE study published in the Journal of the American Heart Association Data included in recent New Drug Application submitted to FDA for two pediatric indications RARITAN, N.J., Sept. 27, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment […]

SeqLL Announces Publication of a New Blood-Based RNA Sequencing Method to Detect Coronary Artery Disease

GW-Led Research uses SeqLL’s tSMS® platform to identify novel signature for detection of coronary artery disease WOBURN, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) — SeqLL Inc. (“SeqLL” or the “Company”) (NASDAQ: SQL), a development-stage life sciences instrumentation and research services company engaged in the development of scientific assets and novel […]

Verve Therapeutics Reports New Preclinical Data with VERVE-101 Demonstrating Robust, Durable and Precise Editing of the PCSK9 Gene for the Treatment of Cardiovascular Disease

Treatment of Non-Human Primates with Clinical Candidate, VERVE-101, Led to Durable Reductions of PCSK9 Protein and Low-density Lipoprotein Cholesterol Comprehensive Off-Target Editing Analysis Using Industry Leading Methods, ONE-seq and Digenome-seq Showed No Off-Target Editing Across 244 Potential Sites in Human Liver Cells Data Support Continued Advancement of VERVE-101 Toward IND Submission […]

FDA APPROVES ABBOTT’S EPIC™ PLUS TISSUE VALVES FOR PEOPLE IN NEED OF MITRAL OR AORTIC VALVE REPLACEMENT

– New enhancements to Abbott’s Epic valve – the most widely used mitral tissue heart valve in the U.S. and globally – can improve implantation and allow compatibility for future transcatheter valve procedures – Epic Plus designed to help patients with more complex cases of aortic or mitral regurgitation or […]

Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management

Guidelines support the Carillon Mitral Contour System® for the treatment of heart failure patients with secondary functional mitral regurgitation KIRKLAND, Wash., Sept. 22, 2021 /PRNewswire/ — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the mention of their […]

Amarin Outlines New Go-to-Market Strategy to Accelerate VASCEPA® (Icosapent Ethyl) Growth in U.S.

Enables Amarin to Drive Additional Demand, Improve Patient Access & Education and Secure Proper Fulfillment and Reimbursement DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 22, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN) today outlined its new Go-to-Market strategy to accelerate growth of VASCEPA® (icosapent ethyl) in the United States, which […]

CARMAT Announces First Implant of Its Total Artificial Heart in a Female Recipient

The procedure was performed at UofL Health – Jewish Hospital by University of Louisville physicians in the first cohort of the U.S. Early Feasibility Study PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need […]

Nuwellis Receives CE Mark for 24-Hour Blood Circuit Set

Certification will help Nuwellis meet clinical and healthcare economic needs in Europe and make outpatient ultrafiltration treatment more accessible EDEN PRAIRIE, Minn., Sept. 21, 2021 (GLOBE NEWSWIRE) — Nuwellis, Inc. (NASDAQ: NUWE), a company focused on providing solutions for patients suffering from fluid overload, today announced that it has received CE Mark […]