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Microsurgical Dilatation

Microsurgical dilatation is indicated for the treatment of lesions in hemodialysis access management (HAM). This innovative technique uses microsurgical blades, mounted to the surface of the balloon, to score a lesion in a uniform manner. By scoring the lesion before and during balloon dilatation, the hyperplasia (tissue overgrowth) that is commonly associated with angioplasty can be reduced and the vessel can be expanded in a manner that is both uniform and precise.

Patients

End-stage renal disease (ESRD) is a form of kidney disease which occurs when both kidneys are impaired or functioning at less than 10 percent of their normal rate. The disease affects more than 500,000 people worldwide every year, nearly 400,000 of them in the U.S. The majority of patients diagnosed with ESRD require dialysis, which is a life saving procedure that cleans the blood using an external machine.

Because most patients require dialysis 2-3 times per week, many patients will receive either a fistula (direct connection of an artery to a vein) or a graft to allow access to the blood stream. Although grafts and fistulae facilitate access to the bloodstream, blockages called stenoses can form within the graft or fistula, obstructing blood flow.

Microsurgical Dilatation is a unique procedure used for treating stenoses within the grafts and fistulae of patients who undergo hemodialysis for ESRD.

Peripheral Cutting Balloon® Device
One of Boston Scientific's leading devices, the Peripheral Cutting Balloon® Device, is used to treat blockages in synthetic or native dialysis fistulae. What makes this device unique is that the Peripheral Cutting Balloon Device utilizes small blades on the balloon’s surface to make acute cuts into the surfaces of the stenoses that block the graft or fistula. The device provides an innovative option to conventional angioplasty because it is designed to reduce trauma on the vessel.

The Peripheral Cutting Balloon Device can be used as stand-alone treatment or in conjunction with other treatment options. The device has been used in Europe and Japan for more than a decade and was approved in 2004 for use in the U.S.