Federal health officials have released an updated warning for medical professionals, about the use of certain aortic endovascular graft systems, after noticing an increased risk of aortic ruptures, known as endoleaks.
A risk management update for various aortic endovascular graft systems was issued by the FDA on June 19, warning about reports of bleeding events occurring after the use of the Endologix AFX with Strata device resulting in Type III endoleaks.
Endovascular graft systems used during endovascular aneurysm repair (EVAR) procedures intended to treat abdominal aortic aneurysms (AAA) and aorto-iliac-aneurysms. The systems use an endovascular stent graft to reinforce the wall of the aorta and to help keep the damaged area from rupturing.
Endovascular grafts are minimally invasive alternatives to open surgical repair for treatment of abdominal aortic aneurysms. Open surgical repair of abdominal aortic aneurysms has a high risk of injury and death, while endovascular grafts can carry fewer such risks.
Despite the benefits of the less invasive procedure, the FDA has found they are prone to cause Type III endoleaks, in which the patient’s abdominal aortic aneurysm is not excluded from the flow and may cause pressure to build up in the aneurysm sac, which could pose a rupturing hazard.
The newly released update by the FDA suggests the Endologix AFX with Stratus device carries a greater risk for causing Type III endoleaks when compared to other endovascular graft systems.
FDA officials estimate the occurrence rate of Type IIIa endoleaks for the AFX with Strata are 0.90 percent at two years and 5.0 percent at five years. Estimated Type IIIb endoleak rates are 0.66 percent at two years and 2.4 percent at five years.
The FDA recommends medical professionals closely monitor patients who have previously undergone implantation with the AFX with Stratus devices, and consider how Type III endoleaks will impact patients during different stages of diagnosis. Officials are advising medical professionals to also discuss all available treatment options to address endoleaks, including the risks and benefits of each.