Coronary/Structural Heart

Cardio Diagnostics Holdings, Inc Announces Expansion of IP Portfolio in Australia with Notice of Allowance of Patent Application

CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a pioneer of artificial intelligence-driven precision cardiovascular medicine tests, today announced that Australia’s Patent Office has issued a Notice of Allowance to the University of Iowa Research Foundation (“UIRF”) for Australian Patent Application No. 2017277666, titled “Compositions and Methods for Detecting Predisposition to Cardiovascular […]

Alucent Biomedical Wins FDA Approval for U.S. Clinical Study

SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology. “AlucentNVS technology is poised to change the standard of care in treating patients undergoing life- and […]

Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+™ Hemostatic Device Usage in Cardiac Surgical Procedures

WAYNE, Pa., Aug. 01, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+™ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a […]

Cadrenal Therapeutics Expands Focus for Tecarfarin to Patients with Implanted Medical Devices for Heart Diseases

PONTE VEDRA, Fla., Aug. 1, 2023 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company focused on developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) for certain rare medical conditions, today announced that the Company is expanding its focus for tecarfarin to patients with implanted medical devices for heart diseases […]

Peijia Medical Announces First Chinese Patient Implanted with TaurusTrio™ Transcatheter Aortic Valve Replacement System

SUZHOU, China, Aug. 1, 2023 /PRNewswire/ — Peijia Medical (HKG:9996), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, announced on July 31, 2023 that the first Chinese patient of the multi-center registration clinical trial for TaurusTrio™ Transcatheter Aortic Valve Replacement (TAVR) system has been enrolled. TaurusTrio™ is […]

First Patients Outside of U.S. Treated with TRIA Polymer Surgical Mitral Heart Valve

SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced that the first 30 patients have been treated outside of the U.S., in the Indian clinical trial of the TRIA™ surgical mitral heart valve. The TRIA mitral valve is designed specifically to accommodate […]

Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve™ Transfemoral System

BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ — Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This innovative heart valve has been granted Breakthrough Device designation for the proposed indication of treatment of severe […]

Anteris Technologies Announces First Successful Implantation of DurAVR™ THV in a Valve-in-Valve Procedure

BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)–Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR), a structural heart company developing DurAVR™ THV, a new class of biomimetic heart valve and the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped to mimic the performance of a native human aortic valve, announces that the DurAVR™ […]

Ionis completes enrollment in landmark Phase 3 CARDIO-TTRansform study in patients with TTR-mediated amyloid cardiomyopathy

CARLSBAD, Calif., July 31, 2023 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced the completion of enrollment in the Phase 3 CARDIO-TTRansform cardiovascular outcomes study of eplontersen in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a large and growing patient population at risk of life-threatening cardiovascular (CV) events. The study enrolled more than 1,400 patients. […]

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

THE WOODLANDS, Texas and REGENSBURG, Germany, Aug. 1, 2023 /PRNewswire/ — The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared […]