Endologix Resumes Shipping for All AFX and Most AFX2 Devices
December 29, 2016–Endologix, Inc. announced that based on positive testing results, it has removed the temporary shipping hold on all sizes of its AFX Endovascular AAA System and some sizes of the AFX2 Endovascular AAA System. The company reported that these products are now available to be shipped to customers and used in procedures, effective immediately. Testing of the remaining sizes of the company's AFX2 system is on-going.
December 27, 2016—Endologix, Inc. announced it will place a temporary hold on shipments of its AFX Endovascular AAA System to complete an investigation of a manufacturing issue for some sizes of the device. The company expects to be able to resume shipments on certain sizes soon but did not specify which sizes. Lifting the hold on the remaining sizes will be dependent on the outcome of the company's investigation.
“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,” commented John McDermott, Chief Executive Officer of Endologix, in the company’s press release. “The manufacturing issue was identified through our ongoing product testing and we are proactively implementing the hold to ensure we always provide the safest possible products for patients.”
McDermott also said that the manufacturing issue with AFX is not related to the manufacturing process for the company’s Nellix and Ovation devices. Both of those devices continue to be available in approved markets.