Endologix Voluntarily Recalls Nellix

Endologix said it was initiating a voluntary recall of the existing inventory of its Nellix endovascular aneurysm sealing system. The Irvine, CA-based company said it was limiting the device to only be available for use under clinical protocol with pre-screened patients that adhere to the current indications. Endologix said it was taking these steps in order to ensure optimal outcomes for patients. 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 (ESVS). “We monitor the performance of the Nellix System through clinical trials, our complaint monitoring system, physician interaction and available publications,” said Dr. Matt Thompson, CMO of Endologix in a release. “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. 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 was developed as an alternative treatment to traditional endovascular aneurysm repair for an abdominal aortic aneurysm. The system is designed to seal an entire aneurysm. The device has approval in E...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news