Endologix Gets IDE Approval For Nellix EndoVascular Aneurysm Sealing System

(RTTNews) - Endologix Inc. (ELGX), Friday said it received Investigational Device Exemption or IDE approval from the FDA to start a pivotal clinical trial to study the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System or EVAS for the endovascular repair of infrarenal abdominal aortic aneurysms.

The study dubbed EVAS FORWARD-IDE is approved to enroll 180 patients at up to 30 sites in the U.S., Canada and Europe. The Nellix EVAS system is a new generation of abdominal aortic aneurysm therapy designed to seal the entire aneurysm with a biocompatible polymer. Endologix was granted CE Mark for the Nellix EVAS System in the 2013 first-quarter and the commercial release of the product in Europe is underway.

"Based on the anticipated enrollment timeline and one-year follow up period, Nellix could potentially be available to physicians and patients in the U.S. in the second half of 2016." said John McDermott, Chairman and Chief Executive Officer for Endologix.