Endologix (ELGX) Receives CE Mark for Nellix Sealing System

January 24, 2013 10:16 AM EST
Endologix, Inc. (Nasdaq: ELGX) announced achievement of the CE (Conformite Europeenne) Mark of the Nellix EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms ("AAA"). Nellix is the first available endovascular aneurysm sealing ("EVAS") system. EVAS with Nellix is an advanced treatment strategy designed to simplify endovascular AAA procedures, treat a broad range of patients, and provide enhanced clinical outcomes. The Nellix System is not approved in the United States for either investigational use or commercial sale.

This approval of the Nellix System includes a few enhancements intended to further optimize the device compared to the previous version, which received CE Mark in October 2012. Endologix expects to begin a limited market introduction of the Nellix System in Europe during the second quarter 2013. The Company will also initiate a post-market clinical study of the Nellix System beginning in the third quarter of 2013 in selected European centers of excellence.

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