AAA sealing system receives FDA breakthrough device designation
Endologix announced that its investigational endovascular abdominal aortic aneurysm sealing therapy has been granted a breakthrough device designation from the FDA.
According to a company press release, the AAA sealing system (ChEVAS) is designed to combine Endologix’s endograft (Nellix 3.5) with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA.
Breakthrough devices receive priority FDA review; the designation allows for early interaction with FDA personnel to expedite the review and approval process.
According to the release, the AAA sealing system is currently under evaluation in the ChEVAS ONE IDE 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,” James McKinsey, MD, professor of surgery at Icahn School of Medicine at Mount Sinai, said in the release. “Our initial clinical results of this therapy have been promising in a challenging group of patients.”
McKinsey is scheduled to present initial findings from the patients he enrolled at the Eastern Vascular Society Annual Meeting on September 26, 2021.
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