Steerocath-T™ Cardiac Ablation Catheters

Prescriptive Information

Refer to the operator's manual for complete instructions for use. 
 
Indications
When using the SteeroCath-T, and Blazer II Ablation Catheters: The Boston Scientific Cardiac Ablation System is indicated for creating endocardial lesions during cardiac ablation procedures to treat arrhythmia.

When using the SteeroCath-A Ablation Catheter: The Boston Scientific Cardiac Ablation System is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia - typically chronic, drug refractory atrial fibrillation.
  
Contraindications
The use of the device is contraindicated in patients with active systemic infection. The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
 
Warnings
Patients undergoing AV nodal modification or ablation of septal accessory pathways are at risk for inadvertent AV block. Pacemakers and implantable cardioverter/defibrillators can be adversely affected by RF signals. Implanted cardioverter/defibrillators should be deactivated during delivery of RF power. Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction. Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures.
   
Potential Adverse Effects
The following adverse events are listed in descending order according to their clinical significance as determined by their severity and frequency (<1% unless otherwise noted with an asterisk). A total of 57 adverse events were observed in the 513 procedures performed during the clinical study. Cardiac/Vascular, Death, Cardiac Tamponade, Perforation, Pericardial Effusion, Cerebral Vascular Accident, Myocardial Infarction, Endocarditis, Pulmonary Edema, Pulmonary Embolism, Venous Thrombus, *Puncture Site Hematoma, Ecchymosis (2.1%), Aortic Valve Insufficiency/Wall Motion Abnormality, Arrhythmic, Permanent Atrioventricular Block, Ventricular Fibrillation, *Non-sustained Ventricular Tachycardia (1.6%), Conduction System Abnormalities, *Atrial Fibrillation, Flutter, Tachycardia (2.5%), Pacemaker Failure-to-sense
    
Cautions
Federal (USA) law restricts these devices to sale by or on the order of a physician. Carefully read all instructions prior to use. Do not rotate the handle and cathteter shaft more than 1 1/2 full rotations (540°). If the desired catheter tip position is not achieved, adjust the catheter's curve to disengage the catheter tip from the heart wall, before resuming rotation of the handle and catheter shaft. It is recommended not to exceed thirty (30) radiofrequency power applications per catheter. Manual prebending of the distal curve can damage the steering mechanism and may cause patient injury. The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. Furthermore, the risk/benefit in asymptomatic patients has not been studied. Placement of the DIP electrode on the thigh could be associated with higher impedance, which could result in automatic RF power shut-off. Regularly inspect and test re-usable cables and accessories. The instrument cables and adapter cables only may be sterilized up to ten times by ethylene oxide sterilization.
    
Trademark
Steerocath-T is a trademark of Boston Scientific Corporation or its affiliates.