www.fdanews.com/articles/197377-tissue-regenix-earns-ce-mark-for-orthopure-xt
Tissue Regenix Earns CE Mark for OrthoPure XT
June 2, 2020
Tissue Regenix has earned a CE mark for its OrthoPure XT, a biological scaffold for use in the treatment of patients with a partial or complete tear of the anterior cruciate ligament (ACL).
The tissue-regeneration device allows reconstruction of other knee ligaments, including multi-ligament procedures following trauma.
The CE mark certification followed positive results from a three-year trial in patients with a partial or complete ACL tear.