Coronary/Structural Heart

Toku joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

SAN DIEGO–(BUSINESS WIRE)–Toku Inc, a provider of an AI-based screening tool for detection of cardiovascular risk through retinal imaging, has joined the American Heart Association Center for Health Technology & Innovation’s (the Center) Innovators’ Network. The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions. The Innovators’ Network is a health care technology consortium that connects entrepreneurs, providers, resea

4DMT Gains Alignment with FDA on Plan to Lift Clinical Hold on Phase 1/2 INGLAXA Clinical Trial for 4D-310 for Fabry Disease Cardiomyopathy

Initiated single non-human primate (NHP) safety study evaluating intravenous 4D-310 combined with rituximab/sirolimus (R/S) immunosuppressive regimen Amended INGLAXA protocol to minimize risk of atypical hemolytic uremic syndrome (aHUS) associated with intravenous (IV) AAV dosing, including addition of R/S immunosuppressive regimen 4D-310 combines a novel, targeted next generation AAV vector (C102) […]

Boston Scientific AGENT™ Drug-Coated Balloon Demonstrates Superiority to Uncoated Balloon Angioplasty in the AGENT IDE Trial

Data from first coronary DCB study in U.S. meet 12-month primary endpoint, demonstrate low adverse event rates with AGENT DCB MARLBOROUGH, Mass. and SAN FRANCISCO, Oct. 25, 2023 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month results from the…

Magenta Medical Reports Positive Results for US Early Feasibility Study of Elevate™ Heart Pump in Providing Temporary Mechanical Circulatory Support During High-Risk PCI Procedures Results presented at TCT 2023 in San Francisco

KADIMA, Israel and SAN FRANCISCO, Oct. 25, 2023 /PRNewswire/ — The US Early Feasibility Study of Magenta Medical’s Elevate™ System, designed to provide temporary mechanical circulatory support during high-risk percutaneous coronary intervention (HR-PCI) procedures, has successfully met…

Positive results from first-in-human completely leadless CRT in the US, published in The Journal of the American College of Cardiology

SUNNYVALE, Calif., Oct. 25, 2023 /PRNewswire/ — EBR Systems, Inc. (ASX:EBR), the medical device company developing wireless cardiac pacing systems, is proud to announce that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States…

TCT 2023: Six-Month Clinical Data from DESyne® BDS Plus Randomized Controlled Trial (RCT) Support Safety and Effectiveness of World’s First Site-Specific Antithrombotic Drug Therapy

SAN FRANCISCO–(BUSINESS WIRE)–Elixir Medical, a developer of novel cardiovascular technologies, today announced positive six-month clinical data from the DESyne BDS Plus Randomized Controlled Trial (RCT) evaluating DESyne BDS Plus, the world’s first triple drug-eluting coronary implant with site-specific delivery of antithrombotic drugs versus a second-generation, durable polymer drug-eluting stent (DES). The study met its primary endpoint of target lesion failure (TLF) with no TLF events rep