Endologix Receives CE Mark Approval for Nellix Sealing System With Refined Indications for Use
September 21, 2017—Endologix, Inc. announced that CE Mark approval was granted for its Nellix endovascular aneurysm sealing system with refined indications for use.
The company stated that following an extensive review of supporting clinical data, it was determined that the refined indications for use for the Nellix system met the applicable safety and clinical performance requirements for CE Mark approval.
This approval of the refined indications for use enable physicians and patients in Europe to continue to have access to the clinical benefits of complete aneurysm sealing, including low rates of endoleaks and all-cause mortality, noted Endologix in its announcement.
In the United States, Nellix is being studied under an investigational device exemption and is not currently available for commercial use.