FDA Grants IDE Approval for Pivotal Trial of Endologix's Nellix System

December 20, 2013—Endologix, Inc. (Irvine, CA) announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a pivotal clinical trial to evaluate the safety and effectiveness of the Nellix endovascular aneurysm sealing (EVAS) system for the endovascular repair of infrarenal abdominal aortic aneurysms (AAAs). 

The study, EVAS FORWARD-IDE, is one of a number of clinical studies that comprise the broader EVAS FORWARD clinical program aimed at establishing clinical and economic evidence for EVAS using Nellix. The EVAS FORWARD-IDE study is approved to enroll 180 patients at up to 30 sites in the United States, Canada, and Europe.

Endologix described the Nellix EVAS system as a new-generation AAA therapy designed to seal the entire aneurysm with a biocompatible polymer. Nellix was developed to simplify procedures, reduce reinterventions, and expand the treatable patient population. Endologix received European CE Mark approval for the Nellix EVAS system in the first quarter of 2013. The commercial release of the product in Europe is currently underway.

Jeffrey Carpenter, MD, serves as the National Principal Investigator for the EVAS FORWARD-IDE study. Dr. Carpenter is Chairman and Chief of Surgery at Cooper University Health Care in Camden, New Jersey. 

In the Endologix press release, Dr. Carpenter commented, “The unique ability of Nellix to seal the entire aneurysm sac is breakthrough technology and is the first meaningful advancement in AAA repair since endovascular grafts were introduced back in the late 1990s. We believe Nellix has the potential to dramatically change the way we treat AAA.”

In the press release, the company advised that based on the anticipated enrollment timeline and 1-year follow-up period, Nellix could potentially be available in the United States in the second half of 2016.