Coronary/Structural Heart

ReValve Solutions Announces Successful First-in-Human Trial with Next-Generation Technology for Transcatheter Mitral Valve Replacement

IRVINE, California–(BUSINESS WIRE)–ReValve Solutions Inc. (ReValve), que ha desarrollado una tecnología de nueva generación para facilitar el reemplazo transcatéter de la válvula mitral, dio a conocer que un hombre de 81 años, con antecedentes de insuficiencia cardiaca, una serie de injertos quirúrgicos de by-pass fallidos y regurgitación de la válvula mitral grave (RM 4+), fue tratado con éxito con el sistema de Palmetto. El procedimiento de reemplazo transcatéter de la válvula mitral de últ

PlaqueTec recruits first ten patients in BIOPATTERN trial

CAMBRIDGE, England–(BUSINESS WIRE)–PlaqueTec, a company identifying endotype-specific biomarkers to advance precision medicine for coronary artery disease (CAD), today announced that it has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval to continue its BIOPATTERN trial following recruitment of the first ten patients with CAD. The trial has been designed to improve understanding of the pathobiology of atherosclerotic cardiovascular diseases (ACVD) and how

SUPIRA MEDICAL, INC., A SHIFAMED PORTFOLIO COMPANY, RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION AS THE COMPANY CLOSED $40M IN SERIES D FINANCING

LOS GATOS, Calif., Nov. 21, 2023 /PRNewswire/ — Supira Medical, Inc., a Shifamed portfolio company, announced today that it has received U.S. Food and Drug Administration (FDA) breakthrough device designation for its Supira System, a next-generation percutaneous ventricular assist device (pVAD). This approval comes as the company closed $40M in Series D financing and prepares […]

Arineta Receives FDA Clearance for its Deep Learning Image Reconstruction Technology in SpotLight™ Cardiovascular CT Scanners

Caesarea, Israel – November 20, 2023 – Arineta Cardio Imaging, a leader in point-of-care cardiovascular CT solutions, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its deep learning image reconstruction (DLIR) technology for use in its SpotLight™ family of cardiovascular CT (CCT) scanners. This next-generation […]

Teleflex Announces First Patient Enrollment in ACCESS-MANTA™ Registry

Registry Intends to Examine Contemporary On-Label Use of the MANTA™ Vascular Closure Device Including Appropriate Patient Selection and Proper Vascular Access WAYNE, Pa., Nov. 16, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the first patient enrollment in a clinical registry […]

Flow Therapy and The Christ Hospital Presenting the Results of EECP® on Angina with No Obstructive Coronary Arteries (ANOCA)

Patients undergoing non-invasive treatment show significant improvement in frequency of chest pain, exercise capacity and quality-of-life markers FORT WORTH, Texas, Nov. 15, 2023 /PRNewswire/ — Enhanced External Counterpulsation (EECP®), a non-invasive treatment that increases blood…

LIB Therapeutics Announces Completion of the Global Phase 3 LIBerate Program of Lerodalcibep, a Novel Third-Generation PCSK9 Inhibitor in Development for Cardiovascular Disease

CINCINNATI–(BUSINESS WIRE)–LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company developing Lerodalcibep, a novel, third-generation PCSK9 inhibitor for patients at very high and high risk of cardiovascular disease (CVD), today announced completion of LIBerate-CVD and LIBerate-HR, the final two registration-enabling Phase 3 trials for patients with CVD or at very high and high risk of CVD. These two trials are part of the registration-enabling Phase 3 LIBerate Pro

New VOYAGER PAD Analyses Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin Across High-Risk and Complex Patient Populations with Peripheral Artery Disease (PAD)

Data presentations at AHA 2023 Meeting reinforce treatment with XARELTO® plus aspirin consistently reduces major cardiovascular events (MACE) as well as major adverse limb events (MALE) in complex patients with PAD Janssen continues commitment to supporting PAD patients with ongoing…