The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.25 mm–4.0 mm) is also indicated for post-delivery expansion of balloon-expandable stents.
Note: Bench testing was conducted with the Sprinter™ Legend™ rapid exchange balloon dilatation catheter and marketed balloon-expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.
The catheter is contraindicated for use in:
- Unprotected left main coronary artery.
- Coronary artery spasm in the absence of significant stenosis.
- Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the procedure for which it is to be used.
- The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.
- Appropriate anticoagulation, antiplatelet, and vasodilator therapy should be administered to the patient.
- When using two guidewires, care should be taken when introducing, torquing and removing one or both guidewires to avoid entanglement. It is recommended that one guidewire be completely withdrawn from the patient before removing any additional equipment.
- 3.75 mm and 4.0 mm Sprinter Legend rapid exchange balloon models are not suitable for simultaneous use within a 2 mm (6F/MGCID 1.8 mm [0.070 in])
guide catheter. Refer to section 9.
Note: In the case of simultaneous use of two Sprinter Legend balloon catheters in 1 guide catheter, care should be taken when introducing, torquing, and removing guidewires and balloon catheters to avoid entanglement.
- Care should be taken not to position two Sprinter Legend balloon catheters in one vessel as inflation in this position may damage the device.
- Care should be taken not to apply excessive force during preparation or use as this may damage the device.
- If the device is kinked, it should not be used.
- When inflating the balloon catheter, observe the pressure monitoring device and/or fluoroscopic image for any loss in pressure. If loss in pressure is observed, cease inflating, apply negative pressure to fully deflate the balloon, remove the balloon catheter, and inspect the system for possible leaks.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner.