Endologix’ ChEVAS System for Aneurysm Deemed FDA Breakthrough Device

The FDA has granted Breakthrough Device status to Endologix’s Chimney EndoVascular Aneurysm Sealing System (ChEVAS) for treatment of complex abdominal aortic aneurysms.

Irvine, Calif.-based Endologix says the system is currently being evaluated in a clinical study that will enroll approximately 120 participants at up to 50 clinical sites worldwide.

The system, which combines Endologix’s Nellix 3.5 endograft with visceral stents, includes sealing technology designed to reduce blood leaks back into the aneurysm sac after endovascular treatments.