Endologix recently announced that the EC Certificate of Conformity (CE mark) for the Nellix endovascular aneurysm sealing system (Nellix system) has been reinstated by GMED, the EU Notified Body for the Nellix system. The reinstatement followed an assessment of clinical evidence.
“We continue to believe that the Nellix system has the potential to transform the treatment of patients with infra-renal abdominal aortic aneurysms,” said Matt Thompson, chief medical officer of Endologix.
He continued: “This therapy continues to generate positive results when used in patients that conform to the anatomical indications for use. We are delighted that the available data supports the reinstatement of our CE mark, and we look forward to utilising this technology to improve the patient experience and drive better outcomes.”
As previously disclosed, the Nellix system will be made available for use at approved centers in a post market clinical investigational setting outside the USA. Within the USA, the Nellix System remains an investigational device as part of the EVAS2 study.
The company does not expect this reinstatement to impact its previously communicated financial guidance for 2019.