The Irvine, Calif.-based company said that the refined indications for use were supported by clinical data and an independent clinical reviewer, and that the device met applicable safety and clinical performance requirements.
“We are very pleased with the clinical outcomes generated by the Nellix EndoVascular Aneurysm Sealing System utilizing the refined IFU. The Nellix CE Mark with the refined IFU provides patients and physicians in Europe with continued access to the clinical benefits of complete aneurysm sealing, including low rates of endoleaks and all-cause mortality,” CEO John McDermott said in a press release.
Endologix originally received CE Mark approval for the Nellix in Sept. 2012, with indications for sealing abdominal aortic aneurysms.
Last week, the company announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair.