Medtronic has received the CE Mark for its Endurant II AAA stent graft system, used to treat patients with abdominal aortic aneurysms (AAA) through a minimally invasive technique called endovascular aortic repair (EVAR).
The Endurant stent graft is a flexible wire frame sewn into a specially woven fabric tube, which can be used by physicians to create a new path for blood flow in the patient’s aorta. The stent graft is delivered through catheters inserted into blood vessels in the groin, and designed to conform to a variety of aortic anatomies.
Erasmus Medical Center in Rotterdam, Netherlands, vascular surgery chief Hence Verhagen said the Endurant II AAA stent graft system would allow vascular surgeons who use EVAR to treat even the most complex AAAs. "Building on the exceptional clinical outcomes of the original system, which has significantly increased the applicability of EVAR, Endurant II offers an even better user experience, which will benefit even more patients whose AAAs are detected before rupturing," he added.
The Endurant II Stent Graft is approved in Europe for the endovascular treatment of abdominal aortic aneurysms in patients with a proximal neck =10mm in length with =60° infrarenal and =45° suprarenal angulation and in patients with a proximal aortic neck =15mm in length with =75° infrarenal and =60° suprarenal angulation.
The Endurant stent graft system is expected to receive US Food and Drug Administration (FDA) approval during 2012.
Abdominal aortic aneurysm is a weakening or bulge in the segment of the aorta that crosses through the abdomen and AAA is often called a "silent killer" as it rarely causes apparent symptoms until rupturing.
Headquartered in Minneapolis, US, Medtronic is the global leader in medical technology alleviating pain, restoring health and extending life for millions of people around the world.