Xeltis today announced successful clinical data from a European trial of its aXess vascular access conduit in hemodialysis treatment. The aXess EU pivotal trial evaluated the patency, safety and performance of the company's restorative vascular access conduit. It looked at adult patients with end-stage renal disease requiring vascular access to … [Read more...] about Xeltis has positive vascular access device data
Xeltis
Xeltis completes enrollment in vascular access conduit study
Xeltis announced today that it completed enrollment in an EU pivotal trial for aXess, its restorative vascular access conduit. The study evaluates aXess in adults with end-stage renal disease. Eindhoven, The Netherlands-based Xeltis will conduct the study in 120 subjects across 22 centers in Europe. This study follows 12-month data from a … [Read more...] about Xeltis completes enrollment in vascular access conduit study
Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Xeltis announced today that it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of arteriovenous fistula (AVF) with the speed to treatment of … [Read more...] about Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
