Dive Brief:

• FDA on Monday alerted patients and healthcare providers that new data it is analyzing points to a higher than expected risk of potentially life-threatening blood leaks with the use of two additional versions of an abdominal aortic aneurysm (AAA) graft device manufactured by Endologix.
• The safety communication comes a year after Endologix recalled its AFX with Strata endovascular graft system due to an elevated risk of blood leaking into the aneurysm compared to similar devices.
• FDA said it is now concerned about the company's AFX with Duraply and AFX2 graft systems in light of data in an abstract published this month in the Journal of the American College of Surgeons by clinicians from seven sites in the Kaiser Permanente integrated healthcare system.

Dive Insight:

In its new safety communication, FDA urged patients who have received any type of Endologix AFX endovascular graft to contact their doctor for further care, to ensure that the device is working as it should.

The graft is a fabric tube supported by a metal framework that is implanted in the aorta to divert blood flow away from the aneurysm and through the device, relieving pressure on the weakened section of the vessel. A leak typically does not have symptoms and could cause the aneurysm to expand and rupture if left untreated, resulting in serious injury or death, FDA said.

"While we continue our evaluation on Endologix AFX endovascular grafts, we want to emphasize the importance of, at least yearly, lifelong follow-up visits for all patients who have any Endologix AFX endovascular graft," Bram Zuckerman, director of the Office of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health, said in a statement accompanying the safety alert.

The Kaiser Permanente clinicians found results they deemed "concerning" in an analysis of 603 endovascular aortic repair procedures using all three variations of the Endologix graft. The data showed 93 (15.4%) leak-related reinterventions and 12 ruptures, with a high two-year cumulative probability of mortality at 9.9%, they said.

"All relevant patients should receive close surveillance and clinical follow-up to prevent device-related adverse outcomes," the Kaiser doctors concluded.

Stifel analyst Mathew Blackman said in a note to investors Tuesday that while the small ​sample (32 patients) examined with AFX2, for example, is a clear limitation of the study, "Endologix will have to continue to vigorously defend the AFX franchise, which could make for some uncertainty about the near-term growth outlook."

FDA said it is continuing to work with Endologix to provide further instructions in labeling all AFX endovascular grafts to address the leak issue. The agency noted it has approved endovascular grafts made by other manufacturers. Medtronic is one such device maker in the AAA repair market.

In a separate action in January, Endologix recalled the existing inventory of its Nellix endovascular aneurysm sealing system, saying off-label use had led to patient outcomes that were not optimal. The system, which takes a different approach to AAA repair than the graft, had its CE mark suspended soon after the recall, but the certification was reinstated in June.

In the U.S., where Nellix was an investigational device, the Irvine, California-based device maker announced in August it received FDA approval to begin a new pivotal study to evaluate the safety and effectiveness of a version of the system. The same month, the company announced an agreement with Boston Scientific to distribute its products in China.