FDA Clears Aptus HeliFX Securement System

November 21, 2011—Aptus Endosystems, Inc. (Sunnyvale, CA) announced that it received 510(k) clearance from the US Food and Drug Administration for the company's endostapling system, which will now be known as the HeliFX aortic securement system, for use during endovascular aneurysm repair (EVAR).

According to the company, the device's helical anchor technology enables independent endograft fixation and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms. The HeliFX system is intended for the repair of endovascular grafts that have migrated from the implant site, have developed endoleaks, or are at risk of developing these complications. The device provides the required augmented fixation and/or sealing to regain or maintain effective aneurysm exclusion. The system also can be used during de novo fixation and sealing mechanisms.

“Long-term failure is arguably the primary impediment to defining EVAR as the new gold standard in aortic aneurysm treatment,” commented David Deaton, MD. “The ability to achieve the physical equivalent of hand-sewn, open surgical repair with the HeliFX system represents not only a fundamentally new endovascular capability, but a possible solution to the vexing problems of late migration and proximal neck dilation that are major causes of late EVAR failure and aneurysm rupture.”

Manish Mehta, MD, added, “The HeliFX system is a leap forward in EVAR technology. The system has applications in preventing as well as managing stent graft migration and type I 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.”

The company noted that approval in the United States allows HeliFX to be used with the Zenith (Cook Medical, Bloomington, IN), Excluder (Gore & Associates, Flagstaff, AZ), as well as the AneuRx, Endurant, and Talent (Medtronic, Inc., Minneapolis, MN) endografts in both initial implant and secondary repair settings. Use with other endografts has not been evaluated to date. The HeliFX aortic securement system received CE Mark approval for use in the European Union in May 2011.