Endologix, Inc. announced on May 26 that its Nellix endovascular aneurysm sealing system had met the primary safety and efficacy endpoints in the EVAS FORWARD-IDE study.
The Nellix system is intended for the endovascular repair of infrarenal abdominal aortic aneurysms. The system received a CE Mark in April.
Endologix submitted results of the prospective, single-arm EVAS FORWARD-IDE study to the FDA as part of its premarket approval submission. The company said the FDA plans on making an approval decision on the Nellix system by the end of 2016 or early 2017.
The study enrolled 150 patients at 30 centers in the U.S. and Europe between January and November 2014. Endologix said there was a 100 percent procedural technical success rate.
Further, 2.7 percent of patients had a major adverse event at 30 days, which met the primary safety endpoint, while the one-year treatment success rate of 94 percent met the primary effectiveness endpoint.
In addition, there was a 96 percent freedom from all-cause mortality, a 99 percent freedom from abdominal aortic aneurysm-related mortality and a 96.6 percent freedom from device-related secondary interventions. Meanwhile, 3.1 percent of patients had endoleaks at one year.
Lead researcher Jeffrey P. Carpenter, MD, of the Cooper Health System in New Jersey, will present full results of the study on June 11 at the Society for Vascular Surgery annual meeting.
In October 2015, Endologix and TriVascular Technologies signed a definitive merger agreement in a stock and cash deal valued at approximately $211 million. For the first quarter of 2016, Endologix's revenue increased 16 percent to $42.4 million, while it posted a net loss of $47.7 million.