Endologix, a developer and marketer of innovative treatments for aortic disorders, announced that the EC Certificate of Conformity 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 MD, Chief Medical Officer of Endologix, Inc. “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 utilizing 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.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company’s focus is in endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once an AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the US.
Source: Company Press Release.