|AneuRx AAAdvantage stent graft. Source: Medtronic|
The FDA Tuesday issued a Public Health Notification warning that patients receiving a stent-graft from Medtronic to treat abdominal aortic aneurysms (AAA) run a greater mortality risk than previously thought.
The agency said the purpose of the notification re-emphasized “the need for continued surveillance of patients treated with endovascular grafts, while providing the public with updated information on the mortality risks associated with the use of Medtronic’s AneuRx Stent Graft System to prevent AAA rupture.”
The Public Health Notification focused on the AneuRx Stent Graft System as it is the only currently marketed device with a significant number of patients with long-term clinical follow-up at five years.
The FDA advisory said that the aneurysm-related death risk among recipients of the Minneapolis-based Medtronic product reaches 1.3 percent by their fourth year of life following the implant, and then 1.5 percent by year five. FDA notices had indicated that late aneurysm-related mortality with the product was about 0.4 percent per year.
Patients who have substantial surgical risk factors such as age and co-morbidities (e.g., cardiac, renal and pulmonary) may experience a higher than average mortality rate for open resection of AAA, the FDA said. The agency noted that for a 70-year-old patient, the rate could range from 2 percent with no risk factors to more than 40 percent with multiple co-morbidities.
Medtronic’s AneuRx was the subject of two previous FDA advisories in 2001 and 2003, after the agency learned of several serious adverse events, including aneurysm ruptures, in patients treated with the stent-graft.
Medtronic is one of several companies that manufacture stent-grafts for the treatment of AAA, according to the Pioneer Press. Analysts say the market for the devices is worth about $100 million to $150 million, with the cost of each stent-graft in the neighborhood of $12,000 to $14,000, the Pioneer Press reported.