CE Mark Suspended for Endologix's Nellix System
January 22, 2019—Endologix, Inc. announced that the CE Mark for the Nellix endovascular aneurysm sealing system has been suspended by its Notified Body, GMED, after a voluntary recall and Field Safety Notification (FSN) issued by Endologix on January 4, 2019. The suspension means that Endologix may not affix the CE Mark to the Nellix system and sell it in the European Union during the term of the suspension.
In the January 4 announcement, the company advised that for the foreseeable future the Nellix system will be made available only for use at approved centers in a clinical investigation setting, with all cases prescreened by a physician panel and supported by Endologix to ensure use in accordance with the current indications and optimal clinical outcomes.
Matt Thompson, MD, Chief Medical Officer of Endologix, stated in the latest announcement, “The notification from GMED is a regulatory action and is not in response to any new information beyond our recent FSN. 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.”