The CE mark for Endologix’ AFX and AFX2 endovascular abdominal aortic aneurysm systems has been reinstated, effective immediately.
The CE mark was temporarily suspended due to reports of Type III endoleaks with a prior generation of the AFX system. The CE mark was reinstated based upon low rates of reported Type III endoleaks with the current generation of AFX products, which was also outlined in a recent letter to physicians provided by the company.
John McDermott, chief executive officer of Endologix, says, “We are pleased that AFX and AFX2 are once again available to physicians and patients in Europe.
