Endologix, Inc., developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption ("IDE") approval from the United States Food and Drug Administration ("FDA") to begin a pivotal clinical trial to evaluate the safety and effectiveness of the Nellix® EndoVascular Aneurysm Sealing System ("EVAS") for the endovascular repair of infrarenal abdominal aortic aneurysms. The study, EVAS FORWARD-IDE, is one of a number of clinical studies that make up 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 U.S., Canada and Europe.
The Nellix EVAS system is a new generation of abdominal aortic aneurysm ("AAA") therapy designed to seal the entire aneurysm with a biocompatible polymer. Nellix is the first and only EVAS product and was developed to simplify procedures, reduce re-interventions and expand the treatable patient population. Endologix received CE Mark for the Nellix EVAS System in the first quarter of 2013 and the commercial release of the product in Europe is currently underway.
Jeffrey Carpenter, MD., Chairman and Chief of Surgery for Cooper University Health Care in New Jersey, is the study's National Principal Investigator. Dr. Carpenter stated, "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."
John McDermott, Chairman and Chief Executive Officer for Endologix, said, "We are pleased to receive IDE approval from the FDA to begin this important clinical trial and look forward to collaborating with the investigators on this exciting new product. We believe Nellix has the potential to improve outcomes for patients and simplify AAA procedures for physicians. 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."