Aptus Endosystems, a developer of endovascular aneurysm repair (EVAR) technology, has received FDA 510(k) clearance for the Aptus EndoStapling system, which will now be known as the HeliFX Aortic Securement System.
The helical anchor technology enables endograft fixation, and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms (AAA). During EVAR, an alternative to open surgical repair of AAA, a catheter-based system is used to implant a metal and fabric endograft to isolate blood flow away from the aneurysm to prevent potential rupture and death.
The HeliFX system is a technology developed to repair endovascular grafts that have migrated away from the implant site, have developed endoleaks or are at risk of developing these complications, which are commonly seen after EVAR. In such cases, augmented fixation and/or sealing is required to regain or maintain aneurysm exclusion. The system also can be used during de novo EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms.
The HeliFX Aortic Securement System received CE mark for use in the European Union in May of this year. Approval in the U.S. allows HeliFX to be used with Cook Medical's Zenith, W. L. Gore's Excluder, and Medtronic's AneuRx, Endurant and Talent endografts in both initial implant and secondary repair settings. Use with other endografts has not been evaluated to date.