A quick reinstatement of the CE Mark for the company's AFX and AFX2 endovascular AAA systems is sending Endologix, Inc. (NASDAQ:ELGX) shares 10% higher at 3:45 p.m. EST Wednesday.
It's been tough sledding for Endologix investors since Dec. 13, 2016 when the company disclosed that EU regulators had suspended the CE Mark on its devices following reports of type 3 endoleaks for its prior generation device.
Endologix voluntarily stopped shipments of its AFX systems in late December to study the problem, but it was able to begin reshipping devices within days after testing them to insure their safety. The reinstatement of the CE Mark in Europe on the systems means a review confirmed that the company has adequately responded to the problem, and that endoleaks aren't likely in the current system.
Endologix is developing Nellix, an endovascular aneurysm sealing system for infrarenal abdominal aortic aneurysms, but that product isn't expected to become available in the U.S. for a while longer. As a result, the company is reliant on the AFX system for its revenue.
The reinstatement of the CE Mark provides investors with a bit more confidence that any drag on sales caused by the endoleaks won't be long lasting. Of course, that's not a given, so until Q4 and Q1 figures are released, investors might want to remain cautious.