On 21 November, the US Food and Drug Administration (FDA) gave 510(k) clearance to Aptus Endosystems for its EndoStapling system, which will be known as the HeliFX Aortic Securement System. According to the FDA this is the first system used to repair a failed aortic endograft.
The HeliFX system provides physicians with a novel technology 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 endovascular aortic repair (EVAR). In such cases, augmented fixation and/or sealing is required to regain or maintain effective aneurysm exclusion. The system also can be used during de novo (initial) EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms.
“Long-term failure is arguably the primary impediment to defining EVAR as the new gold standard in aortic aneurysm treatment,” said David Deaton, associate professor of Surgery and chief, Vascular and Endovascular Surgery, Georgetown University Hospital, Washington, USA. “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 problem of late migration and proximal neck dilation that are major causes of late EVAR failure and aneurysm rupture.”
“The HeliFX system is a leap forward in EVAR technology,” said Manish Mehta, associate professor of Surgery, Albany Medical Center, Albany, USA. “The system has applications in preventing as well as managing stent graft migration and type 1 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 FDA granted approval of the HeliFX system based on review of data from 154 patients who were implanted with 810 EndoStaples. Patients were monitored with routine follow-up CT scans. After a year, none of the EndoStaples had fractured and no patients experienced endograft migration.
“Leakage between the top end of the endograft and the aorta wall is a known complication of endograft implants that can be successfully treated,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The Aptus EndoStapling system provides a less invasive option than open surgery to access and repair these leaks.”
The HeliFX system was CE-marked in May of this year. Approval in the USA allows the system to be used with Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts in both initial implant and secondary repair settings. Use with other endografts has not been evaluated to date.
About HeliFX Aortic Securement System
The HeliFX 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 physician applies one staple at a time around the top edge of the endograft to anchor the device and repair the endograft-artery seal.