Aptus Endosystems has received the US Food and Drug Administration (FDA) 510(k) approval for its HeliFX Aortic Securement system.
The HeliFX system provides physicians with a technology to repair endovascular grafts that have migrated away from the implant site, have developed endoleaks commonly seen after endovascular aneurysm repair (EVAR) procedures.
Albany Medical Center Surgery associate professor Manish Mehta said HeliFX system is a new advancement that gives them 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.
The US approval allows HeliFX to be used with Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts in both initial implant and secondary repair settings.
Aptus Endosystems CEO Jeff Elkins said the intuitive, physician-directed implant technique and HeliFX’s ability to be used with market-leading endografts have the potential to clinically benefit a large number of patients who otherwise have few proven treatment alternatives.