Endologix Announces Recall of Nellix EVAS System, Restricting Use to Prescreened Patients Within Current Indications
January 4, 2019—Endologix, Inc. announced a voluntary recall of all existing Nellix endovascular aneurysm sealing (EVAS) system inventory and the stoppage of unrestricted sales and use of the device, effective immediately.
The decision to enact the recall is to ensure optimal patient outcomes through the most appropriate use of the device, according to the company’s announcement.
Endologix noted it has determined that off-label use is occurring at an unacceptable level, with the consequence of suboptimal results.
“Our independently adjudicated data from the EVAS1 IDE clinical trial indicates that the Nellix system has performed well when used consistent with the current indications,” commented Matt Thompson, MD, Chief Medical Officer of Endologix in the announcement. “However, data from recent Nellix publications leave us concerned that outcomes are suboptimal when the system is used outside current instructions for use.”
The Nellix system will only continue to be available for use under clinical protocol with patients who are prescreened to adhere to current indications. To achieve this, Endologix explained that any potential new cases will be reviewed by a physician panel and supported by the company’s clinical specialists to confirm adherence to protocol.
“Ensuring patient safety and optimal clinical outcomes is our top priority, and the current level of off-label use of the Nellix System cannot continue if we are to protect and preserve the potential for transformative [EVAS] therapy,” said John Onopchenko, Chief Executive Officer of Endologix. “Taking these actions aligns with clinical practice standards, allows us to control off-label use, and will help us ensure appropriate application of the therapy.”
EVAS therapy was designed to overcome the durability issues of conventional endovascular aneurysm repair that have led to high rates of aneurysm-related mortality when compared with surgical interventions, explained Endologix.
Endologix also noted that it has been worked with regulatory authorities regarding the Nellix System recall and related matters to help ensure patient safety and continued appropriate access to the Nellix System.
Compassionate use requests will be reviewed in accordance with the process established by Endologix and associated national competent authorities.