Aptus Endosystems has received FDA clearance for its HeliFX Aortic Securement System, which was previously known as the Aptus EndoStapling System. The product uses helical “EndoAnchors” to provide transmural fixation of endografts in patients with abdominal aortic aneurysms to the aortic wall to enhance sealing and fixation.
The helical anchor technology is designed to mimic the manual hand suturing performed during open surgical repair of abdominal aortic aneurysms. It can be used during EVAR procedures to augment the endograft’s fixation or to repair migrated endovascular grafts or endoleaks or prevent these in patients at risk of developing these complications.
The HeliFX received CE Marking for earlier this year. Under the FDA approval it can be used with Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts in both initial implant and secondary repair settings.
Product page: HeliFX…