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.

HEALTH CARE PROFESSIONALS

Overview

PATIENTS

PRODUCTS FOR THIS PROCEDURE

Healthcare Professionals

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 majority of patients diagnosed with ESRD require dialysis 2-3 times per week.

Access must be created either through a direct connection of an artery to a vein (arteriovenous fistula) or via a graft, which involves connecting a soft, synthetic tube from the end of an artery to the end of a vein. Because of the need for repeated needle sticks during hemodialysis treatments, these access points are prone to stenosis (blockage of a vessel) that leads to decreased blood flow.

Traditionally, clinicians have used percutaneous transluminal angioplasty (PTA) to dilate obstructive lesions of synthetic or native arteriovenous dialysis fistulae. In many cases, the high inflation pressures required for PTA can put unwanted pressure on the vessel wall, causing both barotrauma (injury) to the vessel and pain for the patient. Furthermore, the stubborn make-up of these blockages may also pose a challenge called elastic recoil, where, despite PTA, the treated vessel contracts to a diameter similar to pre-procedural measurements.

Boston Scientific’s Peripheral Cutting Balloon® Microsurgical Dilatation Device is an innovative alternative to conventional angioplasty that has been specifically designed to address these challenges. The Peripheral Cutting Balloon Microsurgical Dilatation Device is similar to a traditional angioplasty balloon, however the balloon also uses 3 or 4 microsurgical atherotomes, that have been added to the balloon’s surface, to score the lesion before it is gently dilated. The atherotomes of the Peripheral Cutting Balloon Microsurgical Dilatation Device create longitudinal incisions within the stenosis, disrupting the fibrotic continuity of the lesion.

The Cutting Balloon 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.