Endologix shares down 16% on its investigation into manufacturing issueStaff Writer | December 27, 2016
Endologix announced a temporary hold on shipments of its AFX Endovascular Endologix System to complete an investigation of a manufacturing issue with some sizes of the device.
Healthcare The temporary hold on AFX
Endologix shares droped 16% on its investigation into medical device manufacturing issue.
"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," said CEO John McDermott.
"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." ■