Irvine-based Endologix LLC, a device maker whose products treats vascular disease, said its ChEVAS System, short for Chimney EndoVascular Aneurysm Sealing, has been granted a Breakthrough Device Designation from the Food and Drug Administration.
The system treats patients with a variety of abdominal aortic aneurysms, or AAA. Endologix currently makes stents and other products to treat AAA, which occur when the lower portion of the body’s main artery becomes weakened.
The FDA Breakthrough Devices Program gives patients more timely access to medical devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The designation comes a few months after now privately held Endologix bought PQ Bypass Inc., a Milpitas-based firm whose first device is intended to address peripheral arterial disease in the lower limbs of the body.
That deal was reported to be in the $300 million range.
ChEVAS is currently being evaluated through a clinical study that is approved to enroll approximately 120 patients at up to 50 clinical sites worldwide.
“The aneurysm sac sealing technology featured in the ChEVAS system is designed to reduce endoleaks, including gutter endoleaks, that are reported after endovascular treatment of complex aneurysms,” said James McKinsey, MD, the leading enroller in the study. “Our initial clinical results of this therapy have been promising in a challenging group of patients.”
