The CE Mark for the Nellix endovascular aneurysm sealing system (Endologix) 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,” explains 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 system will for the foreseeable future be made available only for use at approved centres in a clinical investigation setting, with all cases pre-screened by a physician panel and supported by Endologix to ensure use in accordance with the current indications and optimal clinical outcomes.
Suspension of the CE Mark means that Endologix may not affix the CE Mark and sell the Nellix System in the European Union during the term of the suspension.
Endologix does not expect this action to impact its previously communicated financial guidance for 2019.