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The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

The Peripheral Cutting Balloon™ (PCB) has the features of a conventional angioplasty catheter, with advanced microsurgical capabilities. The PCB features a non-compliant balloon with three or four atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. Upon inflation, the atherotomes score the plaque as the balloon expands and pushes the plaque radially. The scores serve as notches for stress concentration and allow dilatation at lower pressures, minimizing barotrauma. Three of the PCB devices (1 cm, 2 cm and sPCB OTW) are offerred in Over-the-Wire delivery configuration, the sPCB is also available in Monorail configuration. The OTW devices are attached to a Y-connector at one end, the sPCB MR is attached to a female luer. The OTW catheters feature a co-axial shaft consisting of an inflation lumen and a guidewire lumen; the sPCB MR features a proximal shaft using a single lumen hypotube, which is attached to a coaxial distal section consisting of an inflation and guidewire lumen. The guidewire exit port for the sPCB MR is 24 cm from the catheter tip. Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The sPCB devices are coated with Bioslide at the distal section, the 1 cm and 2 cm PCB are coated with MDX 4-4159. The Rated Burst Pressure (RBP) for all devices is 10 atm. The devices are available in nominal balloon diameters from 2.0 mm to 8.0 mm and blade lengths of 1 cm to 2 cm (Tables 1-2).

The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.

The 2 cm Pcripheral Cutting Balloon (2 cm PCB) is a product line extension to the 1 cm Peripheral Cutting Balloon, and uses longer balloons to support 2 cm blades. It is available in nominal balloon diameters of 5.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The catheter body has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire. Radionaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. One end of the catheter is attached to a Y-connector, the other end is attached to the balloon. The Rated Burst Pressure (RBP) of the device is 10 atm. The device is compatible with 0.018" guide wire.