Endologix is recalling its AFX Endovascular AAA Systems in response to reports that leaks are raising the risk of abdominal aortic aneurysm (AAA) rupture.
The device is designed to shield weakened parts of the aorta from the stresses of blood flow but in some cases blood is leaking into the aneurysm sac, leading to a buildup of pressure that could cause the the vessel to burst.
Endologix attempted to address the problem since shortly after the first version of the AFX System came to market in 2011, but now the company is recalling its AFX Endovascular AAA Systems and FDA has identified it as a Class I recall.
Endologix's AFX devices consist of polymer tubes housing metal stents and are implanted during endovascular aneurysm repair (EVAR). The device sits inside the aneurysm and serves as an artificial blood vessel. Rather than push up against the weakened part of the aorta, blood flows through the stent-lined polymer tube that sits inside the blood vessel.
The treatment can go wrong. In Type III endoleaks, a defect or misalignment related to the device allows blood to enter the aneurysm sac. As blood flows into the sac, the pressure applied to the weakened vessel increases, raising the risk of a potentially-fatal AAA rupture.
Type III endoleaks have dogged Endologix for years. In 2013, two years after the AFX System came to market, Endologix began investigating reports of Type III endoleaks. The following year, Endologix stopped making AFX systems with Strata graft material. Endologix pulled that old model from the market in 2016 and advised healthcare professionals to use new versions that looked to be safer.
Since then, patient monitoring has added to evidence that the new models, AFX with Duraply and AFX2 with Duraply, are associated with lower rates of Type III endoleaks. However, Endologix only has three to four years of follow-up data on patients with these devices, compared to up to seven years on people who received the old model. As the rate of endoleaks associated with the old model rose over time, "it is unclear if these devices have fewer endoleaks or if they have not been implanted long enough for endoleaks to occur."
In light of the need for ongoing vigilance, Endologix sent a safety update to physicians in July. The letter provided an update on the rate of Type III endoleaks and shared recommendations about what physicians can do to protect their patients.
Now, the FDA has published a Class I recall notice. The notice reiterates the points Endologix made in its letter to physicians in July. Physicians do not need to return the 61,300 devices affected by the recall. Rather, the FDA wants them to follow the advice Endologix shared in July and report any adverse reactions and quality problems associated with the devices.
The question now is whether the combination of Endologix's changes to the AFX line and advice on how to use the devices will keep down the rate of complications.
The FDA is also continuing to keep tabs on the broader market for endovascular graft systems, which is served by companies including Cordis and Medtronic, but thinks most products on the market are free from the elevated endoleak problem. In June, the FDA told physicians the increased rate of endoleaks it detected in 2017 "appears to be specific" to AFX with Strata.