After Many Missteps, Endologix Makes Progress on Nellix

Endologix just took a big step forward on what has been a long and winding road to FDA approval of its Nellix endovascular aneurysm sealing (EVAS) system. The Irvine, CA-based company said the first patient was treated in its EVAS2 confirmatory clinical study of the device. The Nellix System was developed as an alternative treatment to traditional endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA). The system is designed to seal an entire aneurysm. Endologix originally planned to have FDA approval of the Nellix system by the end of 2016, but the company hit a speed bump about midway through that year at its 100-day meeting with FDA. It was at that meeting that the agency first brought up the possibility of requiring an advisory committee panel meeting due to the novelty of the device. The agency also requested clinical data on the latest version of the Nellix system, which was already available in Europe, leading management to chart a new course and pursue approval for an earlier version of the system that was studied in an earlier investigational device exemption trial. That would have delayed approval by just two or three quarters, but the timeline shifted again in February 2017 when Endologix said it would meet with FDA to discuss newly proposed instructions for use (IFU) to address potential device migration in patients with large amounts of thrombus and present two-year IDE data for the first generation of the device. Another delay occurred in May...
Source: MDDI - Category: Medical Devices Authors: Tags: Medical Device Business Regulatory and Compliance Source Type: news