Endologix has issued a letter to physicians with updated information about the AFX endovascular abdominal aortic aneurysm system.
The voluntary letter, issued after discussions with the US Food and Drug Administration, reviews data from the commercial experience since the original introduction of AFX in 2011. It provides guidance for physicians in the monitoring and postoperative care of patients to address an increased rate of type III endoleaks with the first-generation AFX device (with “Strata” graft material), for which manufacturing ceased in 2014. The letter also includes a voluntary recall of the limited number of first-generation AFX devices remaining in inventories, and some sizes of AFX2 related to the company-issued product hold announced earlier this week, which was based on a manufacturing issue identified during routine internal quality control testing. The company now says it has identified the issue, released all sizes of AFX and some sizes of AFX2 from the hold, and developed a plan to release the remaining sizes of AFX2 as soon as possible.
The letter also describes the enhancements that have been made to the newer AFX and AFX2 devices, updated instructions for use, and the positive initial impact of those enhancements. A copy of the letter is available in the healthcare professionals section of the company’s website (www.endologix.com).
“Endologix is deeply committed to patient safety and excellent clinical outcomes,” said Endologix chief executive officer John McDermott. “We will continue to develop, manufacture and test devices to the highest quality standards and conduct clinical research and post-market surveillance programmes to actively monitor the clinical experience of all our devices. The physician letter and recent temporary hold on AFX/AFX2 demonstrates our unwavering commitment to physicians and patient safety. We look forward to releasing the remaining sizes of AFX2 and working with our notified body to make AFX and AFX2 available in Europe as soon as possible.”
The company also reiterated that the letter regarding the older first-generation AFX device is entirely separate from the hold currently in place for some sizes of AFX2. The recent hold was voluntarily initiated by the company as a precaution based on internal quality control testing and was not based on any reports of adverse clinical results. To date, the reported rates of type III endoleaks with the current version of AFX (with Duraply) and AFX2 are “very low,” a company press release says.
