www.fdanews.com/articles/183743-endologix-receives-ce-mark-for-nellix-endovascular-aneurysm-sealing-system
Endologix Receives CE Mark for Nellix EndoVascular Aneurysm Sealing System
September 29, 2017
Endologix received a CE Mark for its Nellix EndoVascular aneurysm sealing system with refined indications for use.
The Company’s notified body and an independent clinical reviewer determined in a review that Nellix, with refined indications for use, meets the applicable safety and clinical performance requirements.
Nellix is also being studied in the U.S. under an Investigational Device Exemption.