Abstract
FDA has cleared the Aptus EndoStapling System, known already in Europe as the HeliFX™ Aortic Securement System. The innovative helical anchor technology enables independent endograft fixation, and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms (AAA). The device received CE marking in May of this year.
FDA Clearance
Aptus Endosystems, Inc., a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), has announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Aptus EndoStapling System, which will now be known as the HeliFX™ Aortic Securement System.
Background
Aortic aneurysms are an enlarged and weakened section of the aorta, the main artery carrying blood from the heart, which can be lethal if left untreated. Each year, an estimated 200,000 people in the U.S. and 100,000 people in Europe are diagnosed with AAA. In EVAR, an alternative to open surgical repair of AAA, a minimally invasive catheter-based system is used to implant a metal and fabric endograft to isolate blood flow away from the aneurysm to prevent potential rupture and death. Migration or leakage of endografts is a recognised potential risk in their use.
HeliFX in Detail
“The HeliFX system is a leap forward in EVAR technology”
HeliFX is an innovative helical anchor technology which enables independent endograft fixation, and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms (AAA).
The 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 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.
Clinician Comments
“Long-term failure is arguably the primary impediment to defining EVAR as the new gold standard in aortic aneurysm treatment,” said David Deaton, M.D., Associate Professor of Surgery and Chief, Vascular and Endovascular Surgery, Georgetown University Hospital, Washington, D.C. “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, M.D., Associate Professor of Surgery, Albany Medical Center, Albany, NY. “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.”
Company Comments
“The FDA clearance of the HeliFX Aortic Securement System is a major milestone for Aptus and a significant technological advancement in the field of EVAR,” said Jeff Elkins, CEO, Aptus Endosystems. “The intuitive, physician-directed implant technique and HeliFX’s ability to be used with market-leading endografts have the potential to clinically benefit a large number of patients who otherwise have few proven treatment alternatives.”
The HeliFX Aortic Securement System received CE Marking for use in the European Union in May of this year. Approval in the U.S. allows HeliFX 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.
Source: Aptus, FDA
