FDA OKs Device to Treat “Silent Killer”

Approximately 1.2 million people in the United States are being stalked by a “silent killer” in their bodies. An abdominal aortic aneurysm (AAA) is a dangerous bulge caused by a weak spot in the body’s largest artery. It usually has no symptoms—unless it ruptures—which often is deadly. About 75 percent to 90 percent of undiagnosed AAA patients will die if their aneurysm ruptures. The Society for Vascular Surgery recommends treatment for AAAs that are 5.5 cm or greater in diameter. The condition often only is discovered as part of an X-ray or other examination for other reasons.

On Dec. 21., Minneapolis, Minn.-based Medtronic Inc. received approval from the U.S. Food and Drug Administration (FDA) for its Endurant AAA Stent Graft System. Endurant is made of a flexible wire frame sewn into a fabric tube that is used to create a new pathway for blood flow in the patient’s aorta. It is implanted in a minimally invasive procedure through the femoral artery in the groin, which means it does not require open surgery to remove the diseased section of the blood vessel.The stent reinforces the weak spot, reducing the amount of pressure against it.

The FDA gave the thumbs up to Medtronic’s premarket approval application after the company conducted a 150-patient clinical trial at 26 medical centers in the United States. One-year results were reported last month. According to Medtronic officials, there were no post-implant aneurysm ruptures or aneurysm-related deaths in study subjects. In addition, no complications related to leaks or device migration were reported.

“With FDA approval of Medtronic’s Endurant stent graft, U.S. physicians now have access to a new-generation device that will allow safe treatment of even more complex AAA patients with EVAR than was feasible with previous devices,” said Dr. Michel Makaroun, M.D., professor and chief of vascular surgery at the University of Pittsburgh Medical Center, and the principal investigator for the U.S. clinical study. “With its innovative design and delivery system, the Endurant stent graft represents another significant advance that expands our toolkit for the minimally invasive management of this dangerous, often deadly, condition.”

Endurant received CE Mark regulatory approval in Europe in 2008, and currently is in use in approximately 100 countries. The stent will compete against products made by Cook Medical, Gore Medical and Endologix Inc.

Medtronic received FDA approval last month for its Talent Captiva stent graft system to treat aortic aneurysms, a smaller market compared to AAA. An estimated 60,000 people in the United States suffer from the disorder in which a dangerous bulge develops in the main artery near the heart.

The Endurant line has contributed to the 5 percent growth in cardiovascular revenue so far this year, according to the company’s latest earnings announcement. It was one of several new products—including the Resolute drug-eluting stent and Integrity bare-metal stent—that helped grow revenue. Medtronic officials have been vocal about the need for innovation in the cardiovascular sector as they look for ways to boost flat-to-sagging sales.

According to Rick Wise, analyst with Leerink Swan, Medtronic has had to manage through a “challenging growth period, with sales pressured by slowing market growth across most of its businesses, market share losses, and a dearth of new product launches.”