Endologix Inc. (NASDAQ: ELGX) saw its shares hit a multiyear low following a meeting with the U.S. Food and Drug Administration (FDA). After this meeting, the company provided an update that its timeline for the Nellix Endovascular Aneurysm Sealing System (EVAS) may be longer than once thought.
Based on the FDA meeting and other internal analysis, the company has decided to seek U.S. approval of the Nellix EVAS by conducting a confirmatory clinical study with the previously updated Instructions for Use (IFU) and the Gen2 device design, which is currently sold in Europe and other international markets.
