Endologix, a developer of minimally invasive treatments for aortic disorders, has announced that the US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE), which allows the company to initiate the EVAS FORWARD-IDE study.
EVAS FORWARD-IDE study is designed to assess the safety and effectiveness of the Nellix endovascular aneurysm sealing system (EVAS) for the endovascular repair of infrarenal abdominal aortic aneurysms.
The multi-center study will enroll 180 patients at up to 30 sites in the US, Canada and Europe. The study 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.
Nellix EVAS system, a new generation of abdominal aortic aneurysm therapy, is designed to seal the entire aneurysm with a biocompatible polymer.
Endologix chairman and CEO John McDermott noted the company is 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," McDermott added.
The company obtained CE Mark approval for the Nellix EVAS System in the first quarter of 2013 and the commercial release of the product in Europe is currently underway.