Coronary/Structural Heart

Verve Therapeutics Announces 2022 Anticipated Milestones and Preclinical Data on Potential Additional Dosing Regimens for its Novel Base Editing Programs

VERVE-101 Regulatory Submissions and First Patient Treated On-track for Second Half of 2022 ANGPTL3 Program Initiation of IND-Enabling Studies Expected in the Second Half of 2022 Preclinical Data in Non-Human Primates Demonstrate Potential to Re-Dose or Sequentially Dose Base Editing Programs CAMBRIDGE, Mass., Jan. 10, 2022 (GLOBE NEWSWIRE) — Verve Therapeutics, […]

Agilent Presents Thought Leader Award to Professor Jason Kovacic

Victor Chang Cardiac Research Institute (VCCRI) researcher recognized for his influential work on cardiovascular disease SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that Professor Jason Kovacic has been selected to receive a prestigious Agilent Thought Leader Award. Professor Kovacic is being recognized for his influential research on cardiovascular disease—specifically the […]

Regulators Approve Impella 5.5 With SmartAssist in Japan and Hong Kong; US FDA Grants Impella BTR Conditional IDE Approval for First-in-Human Early Feasibility Study

DANVERS, Mass.–(BUSINESS WIRE)–Regulators in three countries have granted approvals to Impella surgical products, as Abiomed (NASDAQ: ABMD) continues to execute its strategy for sustainable growth with new products, new indications and new geographies. In the United States, the Food and Drug Administration (FDA) has granted an Early Feasibility Study (EFS) Investigational Device […]

Medtronic to Acquire Affera

Acquisition to expand company’s cardiac ablation portfolio, including first-time entry into mapping and navigation, within one of the fastest growing medtech markets DUBLIN, Jan. 10, 2022 /PRNewswire(opens new window)/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has entered into a definitive agreement to acquire Affera, Inc., […]

Regeneron and Ultragenyx Collaborate to Commercialize Evkeeza® (evinacumab) Outside the United States

Evkeeza is a first-in-class medicine approved by the U.S. Food and Drug Administration (FDA) and European Commission (EC) to treat an ultra-rare inherited form of high cholesterol TARRYTOWN, N.Y. and NOVATO, Calif., Jan. 7, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Ultragenyx Pharmaceutical Inc. today announced a license and collaboration agreement for Ultragenyx to […]

Cytokinetics and Royalty Pharma Announce Funding Agreements Totaling up to $450 Million

Royalty Pharma Extends Capital to Cytokinetics to Support the Commercial Launch of Omecamtiv Mecarbil and the Further Development of Aficamten Royalty Pharma Purchases Royalties on Future Sales of Aficamten Cytokinetics to Host Conference Call and Webcast Today at 8:30 am Eastern Time SOUTH SAN FRANCISCO, Calif. and NEW YORK, Jan. […]

HELIOS CARDIO ANNOUNCES US FDA 510(k) CLEARANCE FOR A NEW PERICARDIAL AND EPICARDIAL RECONSTRUCTION MATRIX

Offers cardiac surgeons with a best-in-class biomaterial indicated for pericardial repair and reconstruction, and epicardial support and repair WESTON, Mass., Jan. 5, 2022 /PRNewswire/ — Helios Cardio Inc. announces the Food and Drug Administration (FDA) 510(k) clearance for commercial distribution of CardiaMend™ Pericardial and Epicardial Reconstruction Matrix. CardiaMend™ Pericardial and Epicardial Reconstruction […]

Neovasc Announces First Patient Enrollment in COSIRA-II Trial

COSIRA-II Trial Designed to Study the Neovasc Reducer™ for Patients with Refractory Angina VANCOUVER and MINNEAPOLIS, Jan. 05, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced enrollment of the first patient in the COSIRA-II clinical trial. COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a pivotal trial […]

Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study

Amended study design provides immediate access and clinical benefits for all patients and becomes the first global IDE study for PA pressure-guided heart failure management LISLE, Ill., Jan. 5, 2022 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the […]

BIOMODEX and Montreal Heart Institute Team Up to Develop 3D Printed Pulsatile Heart Models

3D models will be used to simulate complex valve repairs in preparation for surgical interventions BOSTON, Jan. 5, 2022 /PRNewswire/ — BIOMODEX®, the leader in biorealistic haptic simulators for physician training and rehearsals, and the Montreal Heart Institute (MHI), a world-renowned, ultra-specialized cardiology center, announced they are partnering to develop a new cardiovascular training solution to […]