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Medtronic Receives FDA Approval For Complete SE Vascular Stent

Medtronic has received approval from FDA for the Complete SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries, major blood vessels within the pelvis that supply blood to the lower extremities.

Medtronic Complete SE Vascular Stent System features several advances, including a dual-deployment delivery system with a triaxial design. The new 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, thereby making deployment easy and precise.

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

According to the Peripheral Arterial Disease Coalition, PAD of the lower extremities affects approximately eight million people in the US, although many patients are unaware of their condition or the seriousness of it. PAD results in a two- to six-fold increase in cardiovascular mortality and an increased risk of amputation, disability and diminished quality of life. It often signals atherosclerosis in the heart and the brain, the PAD Coalition reports.

Robert Molnar, MD of Michigan Vascular Research Center in Michigan, said: “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. 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.”

Sean Salmon, vice president and general manager of Coronary and Peripheral, part of the CardioVascular business, at Medtronic, said: “FDA approval of the Complete SE Vascular Stent System for a peripheral indication marks a successful milestone in our PAD clinical research program.

“Following our acquisition of Invatec, this approval augments Medtronic’s offerings in a large and growing market where patients are significantly under-diagnosed and could benefit from expanded treatment options.”