A Medical Device Daily

Medtronic (Minneapolis) reported two events concerning its endovascular aortic repair business — the international market launch of the Endurant abdominal stent graft system and the first implants of this next-generation medical device in a U.S. clinical trial.

The Endurant stent graft was CE-marked last week, and Medtronic will begin commercialization in mid-July. Outside the U.S., the Endurant system expands the applicability of endovascular aortic repair (EVAR) to more patients with abdominal aortic aneurysms (AAAs), which are present in an estimated 1.2 million people and responsible for 15,000 deaths annually in the U.S. alone.

The new device seeks to address AAA patients whose aortas are highly angulated or whose aneurysms have short necks. The company said patients with these complex anatomies would previously have had no choice but watchful waiting or open surgical repair, in which the abdomen is opened and major organs temporarily moved in order to access the aorta.

In contrast to open surgery, EVAR involves a keyhole procedure in which a stent graft a tube of woven polyester reinforced with a wire skeleton is compressed on a delivery catheter, allowing it to be threaded through the femoral artery and expanded at the site of the aneurysm.

Once in place, the stent graft creates a new path for blood flow, reducing pressure on the aneurysm and the risk of rupture. Left untreated, aortic aneurysms can burst, causing extensive internal bleeding that sometimes lead to death.

The Endurant system is an investigational device in the U.S., where it is limited to investigational use only.