News & Events
Read our recent press releases and follow Vascudyne’s newest advancements
December 19, 2024
Vascudyne Receives Ethics Committee Approval for EU Coronary Artery Bypass Grafting Clinical Trial
Vascudyne announces that it has received Ethics Committee approval for its EU feasibility clinical trial. The EU clinical study follows the successful First in Human study earlier this year in Paraguay, where Vascudyne’s biological tissues were used in coronary artery bypass grafting, without any device related adverse events reported to date.
Following EU Medical Device Regulations (MDR), the proposed clinical feasibility study has been submitted for competent authority approval. Upon approval, the coronary artery bypass grafting clinical trial will commence with surgeon training, site initiation, and patient screening.
Address
Social Media
These are investigational uses that have not been approved by any health authority. Safety and efficacy have not been established and there is no guarantee that pipeline products or investigational uses will receive approval from health authorities.
Copyright 2025 | Vascudyne, Inc.
