Endologix, Inc. (NASDAQ:ELGX) developer and marketer of unique treatments for aortic disorders, reported a provisional hold on consignments of its AFX® Endovascular AAA Arrangement to close a probe of a manufacturing problem with some sizes of the device. The firm projects the temporary hold to be removed for some sizes in the imminent period.
The management speaks
John McDermott, the Chief Executive Officer of Endologix, reported that the provisional hold on AFX is not linked to any reported instances from physicians and they continue to witness extremely good commercial clinical report with the latest versions of AFX2 and AFX.
The manufacturing concern was known through their on-going product assessment and they are proactively executing the hold to ensure they always offer the safest possible items for patients. They consider they will be able to remove the hold on certain sizes in the imminent future, with the timing for the leftover sizes dependent on the result of their investigation. Additionally, the AFX manufacturing issue is not related to the manufacturing procedure for Ovation® and Nellix®, which continue to be accessible in approved markets.
Endologix, Inc., advances and produces minimally invasive therapies for aortic disorders. The firm’s focus is on endovascular stent grafts for the cure of abdominal aortic aneurysms. AAA is a weakening of the aorta wall, the largest artery in the human body, leading in a balloon-like enlargement.
Once abdominal aortic aneurysms develop, it remains to enlarge and, if left uncured, becomes progressively susceptible to rupture. The general patient mortality rate for broken AAA is around 80%, making it a primary cause of death in the U.S. The Nellix EVAS System is a trial device in the U.S.
In the last trading session, the stock price of Endologix declined over 26% to close the day at $5.27. After the recent decline, the market cap of firm stands at 442.87 million.