Endologix Receives CE Mark Approval for Nellix AAA Sealing System

September 6, 2012—Endologix, Inc. (Irvine, CA) announced CE Mark approval of the current version of the company's Nellix endovascular aneurysm sealing system for the treatment of patients with abdominal aortic aneurysms (AAAs). The company advised that the Nellix system is not approved in the United States for either investigational use or commercial sale.

Endologix stated that it is currently implementing enhancements to the Nellix system that will be submitted to its Notified Body for CE Mark approval, which will be followed by a limited market introduction of the enhanced system in Europe by the end of the second quarter of 2013.

In October 2010, Endologix announced that it would acquire Nellix, Inc. (Palo Alto, CA). As described in that announcement, the Nellix platform completely seals and fills the AAA sac, with the goals of preventing device migration and potentially improving clinical outcomes. The device is designed to treat a wide range of aortic anatomies, including those that are outside of the indications for existing endovascular aortic repair devices, such as aortic neck lengths of 5 mm or less, widths up to 34 mm, and iliac aneurysm diameters > 23 mm. Initial clinical results from patients with up to 2 years follow-up have shown 100% implant success, 100% freedom from AAA-related mortality, no aneurysm ruptures, no surgical conversions, and no stent graft migrations, according to the company.