Aptus Endosystems has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HeliFX aortic securement system.
HeliFX provides care providers with a new helical anchor technology to enable endograft fixation.
Manish Mehta, associate professor of surgery at the Albany Medical Center in the US, said the HeliFX system will help prevent and manage stent graft migration and type 1 endoleaks.
”It truly is a new advancement that gives us the ability for precise placement of anchors that attach the stent graft to the aortic wall and enhance fixation, particularly in short and/or angulated aortic necks," Mehta said.
Following the FDA approval, the HeliFX system will be used by Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts in both initial implant and secondary repair settings.