Xeltis has gained a European CE mark for aXess, with 12-month pivotal data of the vascular access graft for haemodialysis demonstrating strong and higher secondary patency versus conventional arteriovenous grafts (AVGs).
Xeltis’s aXess is a bioabsorbable graft for haemodialysis that is injected under the skin, promoting the growth of a patient’s own tissue to form a living, permanent blood vessel.
With the CE mark in hand, the Netherlands-based company intends to initiate commercial activities for its graft across Europe.