Endologix to ensure Nellix System used only within current indications

Endologix announced that in order to ensure optimal outcomes for patients, unrestricted sales and use of the Nellix System will cease immediately, and the product will only be available for use under clinical protocol with pre-screened patients that adhere to the current indications. To ensure optimal clinical outcomes, the Nellix System will, for the foreseeable future, only be available for use under clinical protocol with pre-screened patients that adhere to the current indications. All cases will be pre-screened by a physician panel and supported by Endologix clinical specialists to ensure adherence to protocol. Compassionate use requests will be reviewed in accordance with the process established by the Company and associated national competent authorities. The existing inventory will be voluntarily recalled. These actions are described in a Field Safety Notification issued today. This decision is one of several actions taken by Endologix following a new management mandate in August 2018 to ensure the most appropriate use of each of its devices and is in alignment with a recent publication by the European Society for Vascular Surgery. Endologix has been in contact with regulatory authorities regarding the Nellix System recall and related matters to help ensure patient safety and continued appropriate access to the Nellix System.
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