Aptus Endosystems Inc. landed FDA 510(k) clearance for the first repair system designed to fix leaks and migration in implanted endografts.
An endograft is a tube used to repair a bulge in the wall of the large blood vessel that carries blood away from the heart. Aptus’ HeliFX is a minimally invasive system of staples, delivered via catheter, that allows a surgeon to reach the blood vessel and staple the top edges of the endograft to the tissue to anchor it in place.
"Leakage between the top end of the endograft and the aorta wall is a known complication of endograft implants that can be successfully treated," the FDA Center for Devices & Radiological Health’s office of device evaluation director Christy Foreman said in prepared remarks. "The Aptus EndoStapling system provides a less invasive option than open surgery to access and repair these leaks."
The device is cleared for use with Cook Medical’s Zenith graft; Medtronic’s (NYSE:MDT) AneuRx, Endurant and Talent endografts; and Gore Medical’s Excluder endoprosthesis, according to a press release.
The watchdog agency reviewed the HeliFX system through its de novo reclassification process, a pathway for novel medical devices with no comparable market-cleared predicates which are considered of low-to-moderate risk to patients.
The decision was based on data from a clinical trial of 154 patients who received a total of 810 EndoStaples, according to the FDA. After one year of follow-ups with regular CT scans, there were no incidents of staple fracture and no patients experienced movement in their endografts, although one patient did have an endoleak.
The HeliFX may also be used in the original graft implantation process to enhance existing sealing and fixation mechanisms, according to a press release.
"Long-term failure is arguably the primary impediment to defining [endovascular aneurysm repair] as the new gold standard in aortic aneurysm treatment," Georgetown University Hospital chief of vascular and endovascular surgery Dr. David Deaton said in prepared remarks. "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."
HeliFX won CE Mark approval in the European Union in May of this year.