Today, Xeltis announces that the FDA has approved an Investigational Device Exemption (IDE) submission to begin enrolling patients in a pivotal study for #aXess. This US-based pivotal trial follows strong 12-month data from a first-in-human study in Europe and marks a significant milestone in the company's clinical strategy. aXess is a restorative conduit that allows the formation of a new living vessel for hemodialysis vascular access, providing a better dialysis patient experience. To learn more about the aXess US pivotal trial, see the press release in the comments section below. #FDA #VascularAccess #IDE
Congratulations to Xeltis on this significant milestone!
MCRA’s Cardio and Biocompatibility Regulatory teams are proud to have supported Xeltis with their IDE submission.
Congratutions to the Xeltis team - which are working so hard on providing better lives to heart patients.
Congratulations to the Xeltis team! I have been fortunate to be part of your journey for 9 years and look forward to IDE trial success.
Congratulations Xeltis team, encouraging news
great achievement by the team -- congratulations
Congrats to the Celtics team and much luck going forward!
Well done Xeltis team, major step forward !
Congratulations! Look forward to seeing clinical cases in the US Paulo Neves
Please see the full press release on our website: https://xeltis.com/xeltis-receives-ide-approval-from-fda-for-initiation-of-us-pivotal-trial-for-axess-its-restorative-vascular-access-conduit/