The system is designed to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Endologix has secured a Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Chimney EndoVascular Aneurysm Sealing (ChEVAS) system.
The ChEVAS system is is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy.
The system is designed to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA, by combining the Nellix 3.5 endograft with parallel visceral stents.
AAA occurs when a portion of the abdominal aorta bulges into an aneurysm due to a weakening of the vessel wall. The condition may result in life threatening internal bleeding upon rupture.
Currently, the ChEVAS system is being evaluated through the ChEVAS ONE Investigational Device Exemption (IDE) clinical study.
Endologix has secured approval to enroll approximately 120 patients at up to 50 clinical sites worldwide for the study.
ChEVAS ONE IDE study leading enroller James McKinsey, MD, said: “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.
“Our initial clinical results of this therapy have been promising in a challenging group of patients.”
Endologix is a California-based medical device company that is engaged in innovative therapies for the interventional treatment of vascular disease.
The company develops AAA products on one of two platforms that include traditional minimally invasive endovascular aneurysm repair (EVAR) and endovascular aneurysm sealing (EVAS).
Endologix’s current commercial EVAR products include the AFX 2 device and the ALTO Abdominal Stent Graft System.
In May, the company announced the launch of ALTO Abdominal Stent Graft in Canada, after an approval from Health Canada. The device is also approved for commercial sale in Argentina.
ALTO, which features a patented, sealing technology, is said to be the latest generation in polymer-based therapies for AAA patients.