Endologix has resumed shipments of all sizes of AFX2 endovascular abdominal aortic aneurysm systems. The large diameter sizes of AFX2 were placed on a temporary hold on 27 December, 2016, to investigate a manufacturing issue. Since the hold, the company has been working on process improvements and developed additional testing protocols that have been reviewed by US Food and Drug Administration (FDA). Shipments of the larger sizes of AFX2 resumed on 17 January.
John McDermott, chief executive officer of Endologix, said, “We are pleased that all sizes of AFX2 are once again available to physicians and patients. Following our review of additional testing protocols with the FDA, we have released the remaining sizes of AFX2 from the voluntary shipping hold. We would like to thank our customers worldwide for their support and patience over the past month and look forward to our continued collaboration in the treatment of patients with abdominal aortic aneurysms.”
Endologix also announced the appointment of Laura Nagel as vice president of Global Quality, effective as of 23 January. McDermott commented, “Laura Nagel brings over 25 years of medical device experience, including specific experience with catheter-based technologies in class III cardiovascular devices. She has a great track record across all global quality functions, having successfully built and led high performing teams, developed and tested high quality implantable devices, and managed multiple manufacturing sites. She is also a very patient-focused leader whose values are a perfect fit for the team at Endologix.”
Most recently, Ms. Nagel served as vice president of Quality Assurance at Direct Flow Medical, a company developing and commercialising novel transcatheter heart valve products. From 1997 to 2015, she served in several leadership positions at Edwards Lifesciences and has broad experience in quality assurance, design validation, quality engineering, microbiology, compliance and post-market surveillance. She also has extensive experience dealing with international regulatory agencies.