Raising the bar on performance for Atrial Flutter Blazer Prime® XP Temperature Ablation Catheter and Blazer® Dx-20 Bidirectional Duodecapolar Diagnostic Catheter. Blazer® Dx-20 Bidirectional Duodecapolar Diagnostic Catheter High-performance Blazer® Catheter platform provides consistent steering Bidirectional Duodecapolar Diagnostic Catheter on Blazer Catheter Platform. Blazer® Dx-20 Diagnostic Catheter Super Large Curve. Backsteering and bidirectional to facilitate CS access Curve-lock for stable positioning in CS Soft, extended distal tip 20-electrodes for streamlined electrogram assessment Blazer Prime® XP Catheter One Platform, Multiple Benefits Blazer® Dx-20 Catheter Left anterior oblique fluoroscopic image showing the Blazer Prime® XP Temperature Ablation Catheter and the Blazer® Dx-20 Bidirectional Duodecapolar Diagnostic Catheter spanning the cavotricuspid isthmus. Mapping the Atrial Flutter Circuit I II aVL aVF HRA ABL d ABL HALO 1 HALO 2 HALO 3 HALO 4 HALO 5 HALO 6 HALO 7 HALO 8 HALO 9 HALO 10 Stim 1 Intracardiac electrograms acquired with Blazer® Dx-20 Bidirectional Duodecapolar Diagnostic Catheter (HALO 1 through HALO 10) and with Blazer Prime® XP Temperature Ablation Catheter (ABL and ABLd). Blazer Prime® XP Temperature Ablation Catheter and maneuverability between diagnostic and therapeutic catheters. Better tip stability and durability Fiber-reinforced distal section and more rugged center support optimize tip control and durability: Blazer Prime® XP Catheter Improves lateral contact strength1 Blazer® Dx-20 Catheter Increases backsteering strength 2 Enhances distal torque3 Right anterior oblique fluoroscopic image showing the Blazer Prime® XP Temperature Ablation Catheter and the Blazer® Dx-20 Bidirectional Duodecapolar Diagnostic Catheter spanning the cavotricuspid isthmus. Better Torqueability Extra support in proximal shaft is designed to: Enhances the “push” response from catheter handle to tip Contribute to better overall torque of the catheter Excellent Clinical Results 4 # of Procedures = 250 8mm Tip 10mm Tip 94% Acute Success 96% Chronic Success (6-month follow up) 8% Major Complications 1 2 3 4 Lateral contact bench testing performed by Boston Scientific. N=5. Data on file. Backsteering bench testing performed by Boston Scientific. N=5. Data on file. Distal torque bench testing performed by Boston Scientific. N=5. Data on file. Summary of Safety and Effectiveness Data. Blazer® II XP Cardiac Ablation Catheter. Boston Scientific Corporation, 2003. Bench testing results may not necessarily be predictive of clinical performance. BLAZER PRIME® XP TEMPERATURE ABLATION CATHETER INDICATIONS FOR USE The Boston Scientific Corporation Blazer Prime XP Catheter is indicated for use with the BSC high power Cardiac Ablation Controllers (the Maestro 3000® Controller, the EPT- 1000XP™ Controller, and the EPT-1000XPT™ Controller) and Accessories for the treatment of sustained or recurrent type I atrial flutter in patients age 18 or older. The BSC high power Cardiac Ablation Controllers and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. CONTRAINDICATIONS Do not use this device: in patients with active systemic infection; via the transseptal approach in patients with left atrial thrombus or myxoma; via the retrograde approach in patients with aortic valve replacement. WARNINGS Before operating the device, read these warnings carefully: Peri-procedural anti-coagulation therapy is at the discretion of the physician, however, patients with a history of thromboembolic events may require therapeutic anti-coagulation therapy, during and post-ablation to reduce the incidence of major complications. Because the long-term effects of exposure to ionizing radiation are unknown, careful consideration should therefore be given to pregnant women and pre-pubescent children. Pacemakers and implantable cardioverter/defibrillators can be adversely affected by RF signals. It is important to: a. Retain temporary external sources of pacing available during ablation. b. Reprogram the pacing system temporarily to minimum output or 000 mode to minimize risk of inappropriate pacing. c. Exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent pacing leads. d. Perform complete pacing system analysis on all patients after ablation. Implanted cardioverter/defibrillators should be deactivated during delivery of RF power. Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures. The potential for catheter entrapment may be increased when the catheter is positioned in the chordae tendinae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue. Care must be taken to ensure that any equipment used in connection with the BSC catheters, be type CF, be defibrillation proof, meet EN 60601-1 electrical safety requirements, and comply with all local regulatory requirements for the specified intended use. In the presence of anticoagulation, there may be an increased risk of bleeding from all causes. If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the atrial flutter procedure, there should be a low threshold to perform a transesophageal echocardiogram (TEE) prior to the procedure to confirm absence of thrombus in the left atrial appendage. Do not pass the catheter through any prosthetic heart valve (mechanical or tissue), as this may cause entrapment of the catheter and/or damage to the prosthetic heart valve, resulting in valvular insufficiency and/or premature failure of the prosthetic valve. PRECAUTIONS Observe these precautions, before using the device: Do not attempt to operate the Controller before thoroughly reading the appropriate BSC high power Cardiac Ablation Controller & Accessories Operator’s Manual. The Blazer Prime XP Catheters are intended for use with the BSC high power Controllers and accessories only. The Blazer Prime XP Temperature Ablation Catheter is highly torqueable. Over-rotating the handle and catheter shaft may cause damage to the distal tip or catheter assembly. Do not rotate the handle and catheter shaft more than one and one-half times the full rotation (540 degrees). 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. Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be done under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Excessive bending or kinking of the catheter shaft may damage internal wires. Manual pre-bending of the distal curve can damage the steering mechanism and may cause patient injury. Cardiac ablation procedures should be performed only by physicians thoroughly trained in the techniques of RF Powered Catheter Ablation in a fully-equipped electrophysiology laboratory. Unlike with conventional catheters, a sudden rise in system impedance is not an indication of coagulum formation. Therefore, to minimize coagulum, it is recommended that the catheter periodically be removed and the distal tip cleaned after each line of block. Adequate filtering must be used to allow continuous monitoring of the surface electrocardiograms (ECG) during radiofrequency power applications. When using Blazer Prime XP Catheters, it is required that two Dispersive Indifferent Patch (DIP) Electrode Pads satisfying the requirements of IEC 60601-1/IEC 60601-1-2 be used as the ablation return electrodes or skin burns may result. Use of only one DIP electrode will not allow the operator to fully access the higher power capabilities of the Controller. Placement of the DIP electrodes on the thigh could be associated with higher impedance, which could result in automatic RF power shut-off. During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces. Apparent low power output or failure of the equipment to function correctly at normal settings may indicate faulty application of the DIP electrodes or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication. Regularly inspect and test re-usable cables and accessories. Potential Adverse Events Potential adverse events (in alphabetical order), that may be associated with cardiac catheterization and ablation include, but are not limited to: allergic reaction (including anaphylaxis), angina, arrhythmias, arterial or pulmonary embolism, arterial-venous fistula, atrioventricular node damage (transient/permanent), back pain and/or groin pain, cardiac perforation, cardiac respiratory arrest, catheter entrapment, complete heart block (transient/permanent), cerebral vascular accident, chest pain/discomfort, complications of sedative agents (e.g. aspiration pneumonia), death, effusion (pericardial/pleural), hematoma/bruising, hemoptysis, hemorrhage, hemothorax, hypotension, infection, myocardial infarction, nerve palsy or weakness, pericarditis, phrenic nerve damage/diaphragmatic paralysis, pleurisy, pneumothorax, pulmonary edema, pseudoaneurysm, radiation exposure, sinoatrial node damage, skin burn (defibrillator/cardioverter/radiation), tamponade, transient ischemic attack (TIA), valvular damage, vasovagal reactions, visual blurring. BLAZER® Dx-20 DUODECAPOLAR BIDIRECTIONAL DIAGNOSTIC CATHETER INDICATIONS FOR USE The Boston Scientific Corporation Blazer Dx-20 Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. CONTRAINDICATIONS Caution should be exercised, in the use of these or any other catheters, in patients with prosthetic valves. Patients with recurrent sepsis or with hypercoaguable state should not be considered candidates for transvascular catheters, since the catheter could serve as a focal point for septic or blood thrombus formation. Care should be taken during placement and removal of this or any diagnostic catheter, so as to avoid disturbing permanent internal pacing/defibrillation leads. The Blazer Dx-20 Catheter is contraindicated for transseptal approach in patients with atrial thrombus or myxoma, or interatrial baffle or patch. The Blazer Dx-20 Catheter is contraindicated for use from the femoral approach in patients who have vena cava embolic protection filter devices or known femoral thrombus. WARNINGS The device(s) should be used by physicians thoroughly trained in the techniques of invasive cardiology and in the specific approach to be used. Care must be taken to ensure that any equipment used in connection with the BSC Catheter meet IEC 60601-1 electrical safety and IEC 60601-1-2 electromagnetic compatibility requirements, be type CF, be defibrillation proof, system configurations meet IEC 60601-1-1 electrical safety requirements and comply with local regulatory requirements for the specified intended use. The use of catheters or cables with unprotected male pin connectors presents a risk of electrical hazard. Inadvertent attachment of pin connectors to power supply sockets of connectors could result in electrocution of the patient or operator. Do not use Blazer Dx-20 Catheter as an internal defibrillation catheter. Doing so may result in perforation, arrhythmias, embolism, thrombus, and/or patient death. Diagnostic electrophysiology involves x-ray exposure that presents the potential risk for somatic and genetic effects to both patients and laboratory staff due to the x-ray beam and intensity and duration of the fluoroscopic imaging. Steps should be taken to minimize this exposure as much as possible. Careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be performed under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Stimulation of cardiac tissues caused by pacing stimuli may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns. Do not use if package is opened or damaged. This catheter is not indicated for use in Cardiac Ablation or Coronary Artery Mapping. PRECAUTIONS Excessive bending or kinking of the catheter shaft may damage internal wires. Manual prebending of the distal curve can damage the steering mechanism and/or electrical wires and may cause patient injury. Before using, check shelf life. Do not use catheter after expiration date. ADVERSE EVENTS The following potential risks or discomforts may be associated with diagnostic BSC procedures. The frequency and severity of these adverse events can vary and may necessitate additional medical intervention, including surgery. Allergic reaction, Arrhythmias, Cardiac or respiratory arrest, Cardiac valve damage, Catheter entrapment/entanglement, Chest pain, Damage to vessel intima or cardiac structures, Death, Embolus, air embolus, Hematoma/ecchymosis, Hemorrhage, Hypotension, Infection, Myocardial infarction, Perforation, Pericardial effusion, Pericarditis/pleuritis, Pneumothorax, Pseudoaneurysm, Pulmonary edema, Sinus or AV node injury, Stroke, Tamponade, Thrombosis, Vasovagal reaction, X-ray exposure. Warning Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and or local government policy. CAUTION Federal Law (USA) restricts this device to sale by or on the order of a physician. Carefully read all instructions prior to use. Observe all contraindications, warnings, and precautions noted in these instructions. Failure to do so may result in patient complications. Boston Scientific relies on the physician to determine, assess, and communicate to each patient all foreseeable risks of the procedure. Boston Scientific Corporation 150 Baytech Drive San Jose, CA. 95134 USA Tel: 800-697-9420 Fax: 408-895-2222 For additional information visit: www.bostonscientific.com/electrophysiology Customer Service: 1-888-272-1001 © 2011 Boston Scientific Corporation or its affilates. All rights reserved. EPT-11130_01/2011