Following discussions with the Food and Drug Administration, Endologix, Inc. (NASDAQ:ELGX) has issued updating information to physicians concerning the AFX Endovascular AAA System. The letter containing the updated information is meant to guide physicians on how to provide post-operative care and monitoring of patients. This is with a view to addressing an increase in the rate of Type III endoleaks which was common with the AFX device that ceased production in 2014.
“Endologix is deeply committed to patient safety and excellent clinical outcomes. We will continue to develop, manufacture and test devices to the highest quality standards,” said the chief executive officer of Endologix, John McDermott.
Minimally invasive treatments for aortic disorders
Endologix is involved in the development and manufacture of minimally invasive treatments for disorders associated with the aorta. It mainly concentrates on endovascular stent grafts to treat abdominal aortic aneurysms – a condition resulting from the weakening of the aorta walls characterized by an enlargement that appears as a balloon-like shape.
The letter from Endologix also urges a voluntary recall of the AFX devices which were first-generation and which are still held in inventory. Also, some sizes of the AFX2 would also be voluntarily recalled owing to an issue that cropped up during manufacturing and which was identified when quality control testing was done.
Progress made with AFX and AFX2
Endologix’s letter to physicians also outlines the improvements that have been made with regards to AFX2 and AFX devices. The company also pointed out that the letter addressing the matter of the AFX devices from the first generation is distinct from the AFX2 hold that is in place at present. This particular hold was started by the firm on a voluntary basis as a precaution based on internal quality control testing. It was, however, not motivated by clinical results that had proven adverse. Type III endoleaks that have been reported on the existing AFX versions and AFX2 are quite low.
In Friday’s trading, shares of Endologix Inc edged downwards by 3.38 percent to close the day’s trading session at $5.72 a piece.
