Endologix (NSDQ:ELGX) said today it is temporarily holding shipments of its AFX Endovascular abdominal aortic aneurysm system as it completes an investigation of manufacturing issues with the devices.
The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company.
The hold came only weeks after Endologix had the CE Mark approval for the AFX system suspended over reports of type III endoleaks associated with a previous-gen version of the device.
The Irvine, Calif.-based company expects the temporary hold to be lifted for some sizes “in the near future,” according to a press release.
“The temporary hold on AFX is not related to any reported events from physicians and we continue to see very good commercial clinical results with the latest versions of AFX and AFX2. The manufacturing issue was identified through our on-going product testing and we are proactively implementing the hold to ensure we always provide the safest possible products for patients. We believe we will be able to lift the hold on some sizes in the near future, with the timing for the remaining sizes dependent on the outcome of our investigation. In addition, the AFX manufacturing issue is unrelated to the manufacturing process for Nellix and Ovation, which continue to be available in approved markets,” CEO John McDermott said in a press release.
The company said it implemented “device and graft material improvements and updated instructions for use resulting in a substantial reduction in reported type III endoleaks.”
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.