Endologix Provides Update on Previously Announced Voluntary Nellix System Recall
ENDOLOGIX (ELGX)
Last endologix earnings: 2/19 04:01 pm
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Source: Business Wire
IRVINE, Calif.--(BUSINESS WIRE)-- Endologix® Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that the EC Certificate of Conformity (CE Mark) for the Nellix EndoVascular Aneurysm Sealing System (Nellix System) has been suspended by its Notified Body, GMED, following a voluntary recall and Field Safety Notification (FSN) issued by Endologix on January 4, 2019. “The notification from GMED is a regulatory action and is not in response to any new information beyond our recent FSN,” said Dr. Matt Thompson, Chief Medical Officer of Endologix. “This action is consistent with our previously articulated plans for the Nellix System and does not affect other Endologix products. We remain steadfast in our commitment to patient safety and believe in the transformational potential of Nellix.” Earlier this month, Endologix announced that the Nellix Sys
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