FDA approves HeliFX Aortic Securement System (Actus Endosystems) for treating aortic endografts

The FDA has given 510(K) approval for the HeliFX Aortic Securement System, from Aptus Endosystems, the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large Aortic Aneurysm. The HeliFX Aortic Securement System is a cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter. The catheter is inserted into an artery in the leg and directed through the arteries to the failed endograft. Using a controller on the handle of the catheter, the surgeon applies one staple at a time around the top edge of the endograft to anchor the device and repair the endograft-artery seal. The FDA granted approval based on review of data from 154 patients who were implanted with 810 EndoStaples. Patients were monitored with routine followup CT scans. After a year, none of the EndoStaples had fractured and no patients experienced endograft movement (migration); one subject needed an additional intervention to address an endoleak.