Coronary/Structural Heart

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 […]

OpSens Receives Approval from Health Canada to Initiate First In-Man Study For its New Guidewire For the TAVR Procedure

OPSENS RECEIVES APPROVAL FROM HEALTH CANADA TO INITIATE FIRST IN-MAN STUDY FOR ITS NEW GUIDEWIRE FOR THE TAVR PROCEDURE SAVVYWIRE, the first guidewire that aims to improve procedural efficiency and clinical outcomes for patients undergoing minimally invasive, Trans Aortic Valve Replacement (TAVR) Quebec, Quebec, September 20, 2021 – OpSens Inc. (“OpSens” or […]

Abbott Receives FDA Approval for Minimally Invasive Portico™ with FlexNav™ TAVR System to Treat Patients with Aortic Valve Disease

– Transcatheter aortic valve replacement (TAVR) procedure treats people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery – With Portico approval, Abbott offers the industry’s most comprehensive portfolio of structural heart solutions in the U.S. ABBOTT PARK, Ill., Sept. 20, 2021 /PRNewswire/ — Abbott (NYSE: ABT) […]

Qardio Announces the First Remote Patient Monitoring System to Include a Cardiac Monitoring Service in a Single, Intuitive Platform

SAN FRANCISCO, Sept. 16, 2021 /PRNewswire/ — Qardio, Inc. announced today the launch of the first ever fully remote end-to-end RPM service to include cardiac arrhythmia analysis. QardioDirect (Qardio’s all-inclusive service for RPM) now includes ambulatory Cardiac monitoring to help diagnose atrial fibrillation along with a large range of other arrhythmias. Multiple […]

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial

Company on Schedule to Commence Trial Late This Year VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has received FDA approval for the Investigational Device Exemption (“IDE”) regarding the COSIRA-II IDE Clinical Trial. Following multiple discussions with FDA […]