Endologix (NSDQ:ELGX) said yesterday that the CE Mark approval of its AFX abdominal aortic aneurysm system will be suspended over reports of type III endoleaks with a previous-gen version of the device.
The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company.
The Irvine, Calif.-based company said it has implemented “device and graft material improvements and updated instructions for use resulting in a substantial reduction in reported type III endoleaks,” according to an SEC filing.
Endologix said it has received no reports of type III endoleaks with its next-gen AFX2 system, and anticipates reinstatement of CE Mark approval in the European Union for its AFX and AFX2 in January, 2017.
The company also said it will “share this information and additional background on improvements” to the systems in a letter to physicians during January.
Last month, Endologix saw shares dip approximately 25% after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms.
Endologix said the federal safety watchdog wanted 2-year follow-up data from its EVAS-Forward investigational device exemption study. The additional data submission, expected during the 2nd quarter of 2017, pushes potential pre-market approval from the FDA back to the 2nd quarter of 2018, Endologix said.