The Latest Cardiac and Vascular News
Findings from the admIRE study – freedom from atrial arrhythmia recurrence at 12 months – support the submission of the VARIPULSE™ Platform among U.S. patients IRVINE, Calif., March 25, 2024 /PRNewswire/ — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part…
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular and peripheral disease, today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The DynamX Bioadaptor platform is a medical technology d
ARNHEM, Netherlands, March 11, 2024 /PRNewswire/ — PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, proudly announces the successful achievement of the transition from Medical Device Directive (MDD) CE marking to Medical Device…
NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection […]
DENVER–(BUSINESS WIRE)–Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System. The CAD Staging System is a […]
First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and…
DURHAM, N.C., Feb. 09, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval […]
GREENWICH, Conn.–(BUSINESS WIRE)–Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced a Notice of Allowance for a second US patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator. The patent will provide exclusivity through 2037, with broad claims for the reduction of acute kidney injury and […]
BURLINGAME, Calif., Feb. 5, 2024 /PRNewswire/ — Genesis MedTech, a leading medical device company, today announced the completion of enrollment in its United States Early Feasibility Study (EFS) using its dedicated transcatheter aortic valve replacement (TAVR) system, J-Valve™ Transfemoral (TF) System. Finalizing the EFS marks another significant milestone for Genesis MedTech and its U.S.-based […]
MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., […]
