Medtronic receives FDA approval for new indication for Complete self-expanding vascular stent


The stent is now indicated for treatment of peripheral disease in the iliac arteries

Broadening the scope of innovation for cardiovascular interventions beyond the heart, Medtronic has recently announced that it has received approval from the US Food and Drug Administration (FDA) for the Complete self-expanding vascular stent system to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries. “The Complete 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 of Michigan Vascular Research Center in Flint, USA. “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.”


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


The Complete self-expanding vascular stent system features several novel advances, including an innovative dual-deployment delivery system with a unique triaxial design. The new delivery system is made up of an inner shaft, a retractable sheath and a stabilising 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.


“FDA approval of the Complete stent for a peripheral indication marks a successful milestone in our peripheral arterial disease clinical research programme,” said Sean Salmon, vice president and part of the CardioVascular business, at Medtronic. “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.”


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