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January 16, 2017
Endologix Resumes Shipments of All Sizes of AFX2 Endovascular AAA Systems
January 17, 2017—Endologix, Inc. announced that the company has resumed shipments of all sizes of AFX2 endovascular abdominal aortic aneurysm (AAA) systems. The large diameter sizes of AFX2 were placed on a temporary hold on December 27, 2016 to investigate a manufacturing issue.
On December 29, the company announced it had removed the temporary shipping hold on all sizes of the AFX endovascular AAA system and some sizes of the AFX2 endovascular AAA system.
Endologix advised that the company has been working on process improvements since that time and has developed additional rigorous testing protocols that have been reviewed by the US Food and Drug Administration. Shipments of the larger sizes of AFX2 will resume immediately.
Endologix also announced the appointment of Laura Nagel as Vice President, Global Quality, effective January 23, 2017. Most recently, Ms. Nagel served as Vice President, Quality Assurance at Direct Flow Medical, Inc.
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