FDA Approves Iliac Indication for Medtronic's Complete SE Stent

April 21, 2010—Medtronic, Inc. (Minneapolis, MN) announced that it has received approval from the US Food and Drug Administration (FDA) for the Complete SE self-expanding vascular stent system to be used for treating peripheral artery disease (PAD) in the iliac arteries. Robert Molnar, MD, and William Gray, MD, were coprincipal investigators of the study that contributed to this approval.

“The Complete SE vascular stent system provides physicians with a new treatment option that offers significant benefits for patients with narrowed iliac arteries due to peripheral vascular disease,” commented Dr. Molnar. “The system enables highly accurate stent placement in the iliacs, reducing the likelihood of stent ‘jumping,' which we commonly see during deployment with the use of many self-expanding stent systems.”

According to the company, the Complete SE features a dual-deployment delivery system with a triaxial design. The delivery system is composed of an inner shaft, a retractable sheath, and a stabilizing sheath that reduces friction and allows the retractable sheath to move back freely. This is designed to decrease the amount of force required to deploy the stent, thereby making deployment easy and precise.

Medtronic also stated that its PAD clinical research program is progressing with enrollment in two additional indication-specific trials: One trial is investigating the use of the Complete SE stent for treating superficial femoral artery stenoses, and the other is studying the balloon-expandable Assurant Cobalt stent for treating iliac artery disease.

The company also announced that it has completed the acquisition of Invatec, Inc. (Bethlehem, PA), including two affiliated companies: Fogazzi, which provides polymer technology to Invatec, and Krauth Cardio-Vascular. Invatec, with worldwide headquarters in Roncadelle, Italy, is a developer of devices for treating coronary and peripheral vascular disease.