FDA Clears Medtronic's Abdominal Aneurysm Device

Medtronic Inc. (NYSE:MDT) announced that the U.S. Food and Drug Administration (FDA) approved the medical technology company's device to treat abdominal aneurysm, a blood-filled bulge or ballooning in a part of aorta that runs through abdomen.

More than a million people in the United States have abdominal aortic aneurysm (AAA), which can weaken the aorta and can develop into a potentially serious heath problem. AAA can be fatal if the aneurysm bursts, causing massive internal bleeding.

AAA occur most commonly in individuals between 65 and 75 years old and are more common among men and smokers.

Around 75 percent to 90 percent of undiagnosed AAA patients will die if - or when - their aneurysm ruptures, designating the condition a silent killer.

Medtronic's Endurant stent graft system offers a safe and effective treatment option that doesn’t require major surgery, an extended hospital stay and a long recovery period, it said.

In a study that involved 150 patients, there were no post-implant aneurysm ruptures or aneurysm-related deaths through one year of patient follow-up, and no patients experienced enlargement of their aneurysms, the company said. The study also met its primary goals and endpoints for assessing the safety and effectiveness of the stent graft.

Shares of Fridley, Minnesota-based Medtronic ended Tuesday's regular trading 1.86 percent lower at $36.92.