The US Food and Drug Administration (FDA) has granted breakthrough device designation to Endologix’s Chimney EndoVascular Aneurysm Sealing (ChEVAS) System for treating abdominal aortic aneurysm (AAA) patients.
An investigational endovascular AAA sealing therapy, the ChEVAS System integrates the Nellix 3.5 endograft with parallel visceral stents for the treatment of juxtarenal, pararenal and suprarenal AAA.
At present, the system is being analysed in the ChEVAS ONE Investigational Device Exemption (IDE) clinical study.
This trial will enrol nearly 120 subjects at up to 50 clinical centres globally.
