Valcare Medical Receives FDA Approval to Initiate Early Feasibility Study for its Novel AMEND™ Trans-Septal System
HERZLIYA, Israel and WILMINGTON, Del., March 13, 2025 /PRNewswire/ -- Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ Trans-Septal System for investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS). The AMEND™ Trans-Septal [...]
Valcare Medical, Inc. Expands AMEND TS EU Pilot Study to Italy
TAMPA, Fla., July 25, 2024 /PRNewswire/ -- Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, announces the expansion of the AMEND™ TS EU Pilot Study to Italy. The Italian Ministry of Health has approved the extension to include multiple centers throughout Italy, building [...]
Valcare Medical, Inc. Announces Formation of Scientific Advisory Board with Renowned Mitral Valve Experts
TAMPA, Fla., July 2, 2024 /PRNewswire/ -- Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts. The SAB will provide expert insight and guidance while helping the Company further advance its research [...]
Valcare Medical Announces Enrollment of First Two Patients in AMEND™ TS EU Pilot Study
TAMPA, Fla., May 14, 2024 /PRNewswire/ -- Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, announces the successful completion of the first two enrollments in the AMEND TS European pilot study. Dr. Bruno Melica and the team from Vila Nova de Gaia Hospital, Portugal, performed the procedures. [...]
Valcare Medical, Inc. Announces Corporate Restructuring and Appointment of New CEO
TAMPA, Fla., April 24, 2024 /PRNewswire/ -- Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced a comprehensive corporate restructure by a group of investors led by Techwald Next, aimed at accelerating the company's plans to initiate the AMEND mitral annuloplasty clinical studies in Europe and the United [...]
Valcare Medical Announces First-in-Human Transseptal Implant of the AMEND™ Annuloplasty Ring for Mitral Valve Repair
Israeli heart valve device developer Valcare Medical today announced the 1st implantations of its Amend mitral valve repair annuloplasty ring, completing the 1st phase of its 1st-in-human multi-center clinical trial evaluating the device.