Endologix (NSDQ:ELGX) said it won FDA Investigational Device Exemption for its Nellix endovascular aneurysm sealing system, paving the way for a U.S. clinical trial.
The EVAS Forward-IDE study is expected to enroll 180 patients at 30 sites throughout the U.S., Canada, and Europe. Researchers will test the safety and effectiveness of the Nellix device for endovascular repair of infrarenal abdominal aortic aneurysms.
The Nellix is designed to prevent vascular leaks and thus reduce the need for secondary interventions following endovascular AAA repair. The device landed European CE Mark in the 1st quarter of 2013, according to a press release.
“We believe Nellix has the potential to improve outcomes for patients and simplify AAA procedures for physicians," chairman & CEO John McDermott said in prepared remarks. "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 2nd half of 2016."
Endologix recently announced a convertible notes offering, seeking to raise up to $75 million, hoping to fund expansion efforts, clinical trials and other corporate activities.
