FDA Clears Self-Expanding Stent for the Iliacs


April 22, 2010

April 22, 2010 – Broadening its product scope into the peripheral artery disease market, Medtronic today received U.S. Food and Drug Administration (FDA) clearance for the Complete SE Vascular Stent System. The self-expanding stent is indicated for used for the treatment of peripheral arterial disease (PAD) in the iliac arteries.

“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,” said Robert Molnar, M.D., of Michigan Vascular Research Center in Flint, Mich. “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.”

Dr. Molnar and William Gray, M.D., director of endovascular intervention at NewYork-Presbyterian Hospital/Columbia University Medical Center, led the study (as co-principal investigators) that contributed to this approval.

The stent features a dual-deployment delivery system with a triaxial design. The delivery system is made up of an inner shaft, a retractable sheath and a stabilizing sheath that reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, making deployment easier and precise.

The stent marks Medtronic’s entry into the peripheral vascular market. The company also purchased Invatec recently, which specializes in PAD treatment devices.

In other areas of Medtronic’s PAD clinical research program, physicians are progressing with enrollment in two additional indication-specific trials. One trial is investigating the use of the Complete SE stent for the treatment of superficial femoral artery stenoses. Another is studying the balloon-expandable Assurant Cobalt stent in treating iliac artery disease.

The Complete SE was originally cleared in 2007 for use as a biliary stent to treat malignant neoplasms in the biliary tree.

For more information: www.medtronic.com