Endologix has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a multi-centre study for assessing the safety and effectiveness of its Nellix endoVascular aneurysm sealing system for the endovascular repair of infrarenal abdominal aortic aneurysms.
EVAS FORWARD-IDE will enroll 180 patients at up to 30 sites in the US, Canada and Europe. This study is one of a number of studies that makes up the broader EVAS FORWARD clinical programme aimed at establishing clinical and economic evidence for EVAS using Nellix.
Endologix has designed the Nellix EVAS system, a new generation of abdominal aortic aneurysm therapy, to seal the entire aneurysm with a biocompatible polymer.
According to the company, Nellix is an innovative new endovascular aneurysm sealing system designed to simplify endovascular procedures, treat a broader range of patients, and provide enhanced clinical outcomes.
Endologix chairman and CEO John McDermott said: "We believe Nellix has the potential to improve outcomes for patients and simplify AAA procedures for physicians. Based on the anticipated enrolment timeline and one-year follow up period, Nellix could potentially be available to physicians and patients in the US in the second half of 2016."
In January, the company obtained CE Mark approval for the Nellix system for the treatment of patients with abdominal aortic aneurysms. This approval includes a few enhancements intended to further optimise the device compared with the previous version, which obtained CE Mark in October 2012.
The company is in the process of commercially launching the product in Europe.