June 18, 2018
FDA Issues Update Regarding Type III Endoleak Risks
June 19, 2018—The US Food and Drug Administration (FDA) announced an update to its 2017 advisory regarding the risks associated with type IIIa and IIIb endoleaks with various aortic endovascular graft systems indicated for endovascular aneurysm repair (EVAR) procedures in the treatment of abdominal aortic aneurysms (AAAs) and aortoiliac aneurysms.
In September 2017, the FDA issued a letter addressed to vascular and cardiothoracic surgeons, radiologists, and cardiologists stating that an increase in the occurrence of type III endoleaks had been suggested by several sources, including the FDA's Medical Device Reporting system and the Annual Clinical Updates to Physicians by the manufacturers.
Based on new information, the FDA now advises that the increased risk for type III endoleak appears to be specific to one device, the AFX with Strata device (Endologix, Inc.), which has a greater risk for a type III endoleak compared with other endovascular AAA graft systems. Endologix has not manufactured the AFX with Strata graft material since July 2014. In a December 2016 letter to physicians, the company requested that all AFX with Strata devices be removed from hospital inventory. However, there are patients who have previously undergone implantation of the device.
The FDA noted that the company provided data in the December 2016 letter that estimated type IIIa endoleak rates for the AFX with Strata are 0.9% at 2 years and 5% at 5 years. Estimated type IIIb endoleak rates are 0.66% at 2 years and 2.4% at 5 years. Because they were calculated using voluntary reporting and units sold, the rate estimates may be low compared with the true endoleak event rates.
The FDA's recommendations for health care providers who follow patients treated using the AFX with Strata device and with any endovascular AAA graft system are outlined in the current update, available online here.
Matt Thompson, MD, Chief Medical Officer for Endologix, stated, “On September 28, 2017, the FDA issued a letter to health care professionals (HCPs) to raise awareness of an increased occurrence of type III endoleaks after EVAR. Today, the FDA issued an update to this letter to reinforce awareness of type III endoleaks with the AFX Strata system. Endologix previously communicated these data to HCPs in a safety notice dated December 2016."
Dr. Thompson continued, "Today’s FDA update does not disclose risks beyond those already communicated to HCPs in Endologix’s December 2016 safety notice, which requested that all remaining AFX Strata devices be returned from the field and emphasized the facts that Endologix has not manufactured AFX Strata grafts since 2014 nor has it sold any AFX Strata grafts since 2016.”
John Onopchenko, Chief Executive Officer of Endologix, commented, “Endologix is committed to working collaboratively with the FDA, in this case, to reinforce recommendations for managing patients implanted with AFX Strata. Our current commercially available versions of the AFX system, the AFX Duraply and AFX2 products, are manufactured using a different expanded polytetrafluoroethylene processing methodology and include additional product improvements. These AFX Duraply and AFX2 products are not the subject of today’s FDA-issued awareness notification."
Mr. Onopchenko further stated, "Through our comprehensive system of postmarket surveillance, anonymized registry data, and the only randomized trial to compare EVAR systems (the LEOPARD trial), we have a strong and growing evidence base that supports the use of the AFX Duraply and AFX2 systems for patients with AAA. We are proud of, and committed to, advancing our collaborative work with the FDA on behalf of our patients, customers, and the broader clinical community.”