Endologix is reportedly lowering its revenue growth outlook to flat- to low-single digits. The company has previously said it expects mid-single digit growth for 2017.
The Irvine, Calif.-based company’s management commented on Endologix’s outlook at the 35th JP Morgan Healthcare Conference, according to a report from Leerink.
The company has not made a formal statement regarding its guidance for 2017.
The analyst wrote that Endologix is probably going to see further downward estimate revisions, especially given the regulatory and quality issues that came to light in December last year.
The company put a temporary hold on shipments of its AFX Endovascular abdominal aortic aneurysm system to investigate manufacturing issues with the devices. Endologix had the CE Mark approval for the system suspended in early December over reports of type III endoleaks associated with an older version of the device.
The company said it made “device and graft material improvements and updated instructions for use resulting in a substantial reduction in reported type III endoleaks.”
Endologix said it has not received any reports of type III endoleaks with its updated AFX2 system, and anticipates that its CE Mark will be reinstated in the European Union for its AFX and AFX2 this month.