Indications for Use: The Volt™ PFA Catheter, Sensor Enabled™ is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal or persistent (episode duration less than one year) atrial fibrillation when used in conjunction with a compatible pulsed field ablation (PFA) generator. The catheter is compatible with the EnSite™ X EP System. Contraindications: The Volt™ PFA Catheter, Sensor Enabled™ is contraindicated for: ▪ Patients who have had a ventriculotomy or atriotomy within the preceding four weeks. ▪ Patients with prosthetic valves as the catheter may damage the prosthesis. ▪ Patients with an active systemic infection as this may increase the risk for cardiac infection. ▪ Patients with a myxoma or an intracardiac thrombus as the catheter could precipitate an embolus. ▪ Patients unable to receive heparin or an acceptable alternative to achieve adequate anti-coagulation. The transseptal approach is contraindicated in a patient with an interatrial baffle or patch because the opening could persist and produce an iatrogenic atrial shunt. The retrograde trans-aortic approach is contraindicated in patients who have had aortic valve replacement. Warnings: Misuse of this device may result in serious complications. Do not alter this device in any way. This device is intended for one time use only; do not reprocess or reuse it. Note the product “Use by” date on the package. Any attempt to resterilize and reuse this system may compromise its integrity. Adverse effects of using nonsterile components may include, but are not limited to: ▪ Local or systemic infection or reaction ▪ Mechanical damage ▪ Inaccurate functionality. For both patients and laboratory staff, cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects due to the x-ray beam intensity and duration of the fluoroscopic imaging. Carefully consider the use of this device in pregnant women. This device should be used by physicians trained in the techniques of catheter ablation in a fully equipped electrophysiology laboratory. Do not immerse the proximal handle or cable connectors in fluids; electrical performance could be affected. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Vascular perforation or dissection is an inherent risk of any catheter placement. Careful catheter manipulation must be performed to avoid device component damage, thromboembolism, cerebrovascular accident, cardiac damage, perforation, pericardial effusion, or tamponade. The safety and long-term effects of lesions created by pulse field ablation have not been established. In particular, the long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. The safety and effectiveness of the device has not been established in pregnant women or pre-pubescent children. Careful consideration must therefore be given for the use of the device in pregnant women or prepubescent children. Concurrent use of non-linear catheters within the atrial chamber may increase the risk of entanglement. Catheter entanglement with other device is a possible complication of electrophysiology procedures. To unentangle the Volt™ PFA Catheter, Sensor Enabled™, deflate the balloon and manipulate the opposing catheter to the center of the basket electrodes. Follow any relevant entanglement procedures from the opposing device. Aspiration during catheter introduction or withdrawal is recommended to limit the potential for air ingress into the patient. During catheter preparation, rinsing or submerging the basket in saline reduces the potential for blood coagulation. During catheter preparation, shifting the straightener over the basket removes any residual air remaining in the folds of the balloon and reduces the potential for air embolism. Use of a syringe larger than 12 mL for balloon inflation increases the risk of overinflation. This can result in detachment of the spline electrodes at the distal coupler. Pacemakers and implantable cardioverter/defibrillators can be affected adversely by PFA signals. It is important to: ▪ Have temporary external sources of pacing and defibrillation available during ablation. ▪ Deactivate ICDs because they can discharge and injure the patient or even damage the ICDs during the ablation procedure. ▪ Exercise extreme caution while ablating near atrial or ventricular permanent pacing leads. ▪ Perform complete pacing system analysis on all patients after ablation. Precautions: Do not deflect the introducer while the basket is within the deflectable portion of the introducer, as this can cause damage to the introducer deflection mechanism. Do not deflect the Volt™ PFA Catheter, Sensor Enabled™ while the basket is in the introducer, as this can cause damage to the catheter deflection mechanism. The first application of PFA will likely result in a significant reduction of amplitude of PV potentials recorded from the electrodes on the catheter. Do not use this as an immediate indication that no further ablation is necessary. The PFA therapy should be delivered in accordance with the Therapy Delivery Parameters. Advance the catheter slowly through the introducer to minimize the risk of air embolism. Do not attempt to use the device before completely reading and understanding the applicable instructions for use. Inspect the package prior to use. Do not use if the packaging or catheter appears damaged. Inspect all components before use. Excessive bending or kinking of the catheter may cause damage to the catheter. Be careful not to twist the electrodes with respect to the catheter shaft; twisting may damage the electrode bond and loosen the electrodes. Release the steering (make the catheter straight) prior to pulling back the catheter into the introducer. Deflate the balloon before pulling the catheter back into the introducer. Overinflation of the balloon may cause damage to the device. Always straighten the catheter shaft and keep the balloon deflated before insertion or withdrawal. Do not use if the catheter appears damaged, kinked, or if there is difficulty in deflecting the distal section to achieve the desired curve. Do not use if the catheter does not hold its curve or if there is difficulty deflecting the catheter. Do not use if there is difficulty inflating or deflating the balloon. Do not use excessive force to advance or withdraw the catheter while inside the introducer when resistance is encountered to avoid potential damage to the catheter. Do not expose catheter to organic solvents such as alcohol. Catheter advancement must be performed with support from visualization modalities such as Intracardiac echo, fluoroscopy, and or compatible navigation and visualization systems to minimize the risk of cardiac damage, perforation, or tamponade. If other catheters are used concomitantly with the Volt™ PFA Catheter, Sensor Enabled™, only use other catheters in close proximity when the balloon is inflated, and never in tandem with the catheter in the same pulmonary vein. Never retract the catheter into the introducer when another catheter is in close proximity. Never use a loop catheter concomitantly with the Volt™ PFA Catheter, Sensor Enabled™ within the same atrial chamber. Retract the catheter into the introducer before using a loop catheter within the same chamber. Prior to therapy delivery, ensure that the guidewire is not touching the basket electrodes to prevent ineffective therapy. Compliance with intended therapy delivery parameters reduces the potential for hemolysis and acute kidney injury. Ensure that vacuum pressure is relieved and balloon is fully deflated. After deflating the balloon, leave the stopcock open between the syringe and the inflation lumen to prevent catheter damage during catheter withdrawal. It is recommended to withdraw the guidewire into the introducer prior to balloon deflation to avoid potential entanglement with spline electrodes. Ensure even spacing for splines and full balloon inflation to reduce potential for generator fault detection. Ensure connection to center lumen stopcock when attempting to inject contrast. The balloon inflation lumen has a blue/grey striped sleeve to visually distinguish it from the center lumen stopcock. Do not touch the guidewire during therapy delivery. Risk of electric shock to the user is possible under rare circumstances in which the guidewire is in contact with an active therapy electrode(s) and the user. During treatment with the catheter, ensure there is no possibility of contact with electrodes from another catheter. To avoid thromboemboli, intravenous heparin should be used when entering the left heart during ablation. Consult the HRS consensus guidelines for anticoagulation strategies pre-, during, and post-catheter ablation. Individual patient anatomy and physician technique may require procedural variations. Maintain an activated clotting time (ACT) of greater than 300 seconds at all times during use of the catheter. Store in a dry place. After use, the device accessories and packaging should be appropriately classified for disposal, e.g. biohazard, sharps, non-hazardous waste etc., and carefully disposed of in compliance with facility procedures and applicable laws and regulations. Catheter materials are not compatible with magnetic resonance imaging (MRI). Potential Adverse Events: The potential adverse events may be related to the ablation catheter(s) and/or the interventional procedure. The severity and/or the frequency of these potential adverse events may vary and may result in prolonged procedure time and/or additional medical and/or surgical intervention, implantation of a permanent device such as a pacemaker, and in rare cases, may result in death. The following adverse events have been documented for catheter ablation procedures: ▪ Abnormal vision ▪ Acute kidney injury ▪ Air embolism ▪ Anesthesia reaction ▪ Angina/chest pain/discomfort ▪ Aorto-right atrial fistula ▪ Arrhythmias, including exacerbation of preexisting atrial fibrillation ▪ Arteriovenous fistula ▪ AV/SA node stunning (asystole) ▪ Bleeding, including major bleeding requiring surgery or transfusion/hematomas/anemia ▪ Cardiac perforation/tamponade ▪ Cardiac embolism ▪ Cardiovascular injury, including atrial trauma and coronary artery/pulmonary vein trauma ▪ COPD exacerbation ▪ Component damage to Implantable Cardioverter Defibrillator(ICD) or implantable pacemaker ▪ Coronary artery spasm ▪ Cytotoxicity/systemic toxicity/sensitization/endotoxin/pyrogen ▪ Death ▪ Dislodgement of ICD or pacing leads ▪ Electrical shock ▪ Endocarditis ▪ Esophageal lesion ▪ Fever ▪ Foreign body embolism ▪ Heart block/unintended ablation ▪ Heart failure ▪ Hemothorax ▪ Hypotension ▪ Infectious pericarditis ▪ Left atrial esophageal fistula ▪ Myocardial infarction ▪ Neck/back/groin/chest pain/discomfort (general chest pain not associated with MI) ▪ Palpitations ▪ Pericarditis ▪ Pericardial effusion ▪ Phrenic nerve injury ▪ Peripheral vascular dissection/laceration ▪ Pleural effusion ▪ Pneumonia ▪ Pneumothorax ▪ Pseudoaneurysm ▪ Pulmonary edema ▪ Pulmonary embolism ▪ Pulmonary hypertension ▪ Pulmonary vein stenosis ▪ Radiation injury ▪ Respiratory failure/distress/depression/hypoxia ▪ Silent cerebral event/lesion ▪ Stiff Left Atrial Syndrome ▪ Stroke/cerebrovascular accident ▪ Syncope/vasovagal reaction/dizziness ▪ Transient ischemic attack (TIA) ▪ Thromboembolism ▪ Thrombosis/thrombus ▪ Vagal nerve injury including Gastroparesis ▪ Valvular damage or insufficiency
Indications: The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures. Warnings: For patient safety, any connections that directly connect the patient to the EnSite™ X EP System must be routed through the appropriate modules: EnSite™ X EP System SurfaceLink Module, EnSite™ X EP System 20 pin Catheter Input Module, EnSite™ X EP System 80-pin Catheter Input Module and Direct Connect Ports on the EnSite™ X EP System Amplifier. When using the EnSite™ X EP System, full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables. Refer to the ablation catheter IFU for a listing of adverse events related to the use of this device in conjunction with ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. Non-SE catheters cannot collect location data and should not be used for navigation in VoXel Mode because they do not have a magnetic sensor. However, they can be visualized and display intracardiac signals. Only connect items that have been specified as part of the EnSite X EP System or compatible with the EnSite X EP System to the multiple socket-outlets. The EnSite™ X EP System model display should be used in conjunction with conventional EP techniques to confirm catheter location. The AutoMark feature does not indicate lesion effectiveness. AutoMarks are placed based on user-defined parameters for catheter stability and RF metrics only. PFA AutoMarks are placed based on electrode location and user-defined PFA metrics only. Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices) may create a location shift. The 2D and 3D LivePoint Displays should not be used as the primary / sole display of tissue proximity during an Electrophysiology study. Refer to the Current PFA Generator IFU for warnings related to the Volt ™ LivePoint Display. Precautions Ensure that surface electrodes, Patient Reference Sensors, and associated connectors do not contact one another, electrical ground, or metallic objects. Do not operate the EnSite™ X EP System Field Frame within 10 m of another operating Field Frame. Do not place the EnSite™ X EP System Field Frame Cable inside the measurement volume or wrap it around the EnSite™ X EP System Field Frame, as it may create a magnetic interference. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may cause metal distortion. Do not place tool cables within 30 mm of the EnSite™ X EP System Field Frame Cable. If placed this close-particularly if the cables are parallel to each other the tool cable may become subject to electromagnetic interference.Do not use the EnSite™ X EP System for magnetic catheter localization or magnetic data collection (NavX SE or EnSite VoXel point collection) if other magnetic fields are present.
Indications: The ViewFlex™ X ICE Catheter Sensor Enabled™ is indicated for use in adult and adolescent pediatric patients for intra-cardiac and intra-luminal visualization of cardiac and great vessels anatomy and physiology, as well as visualization of other devices in the heart. When used with a compatible three-dimensional mapping system, the catheter provides location information. The ViewFlex™ X ICE Catheter Sensor Enabled™ is contraindicated if there is an occurrence of conditions which create unacceptable risk during catheterization. If the patient has a mechanical tricuspid valve (a prosthetic tissue valve is permissible). in patients with an active systemic infection as this may increase the risk for cardiac infection. when there is a presence of deep venous thrombosis or abnormalities or when there is no adequate vascular access. for use in the left side of the heart for patients unable to receive heparin, or an acceptable alternative, to achieve adequate anticoagulation. when there is a presence of a known intracardiac thrombus in a chamber, other chambers are open to use, and via the transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. in the coronary vasculature due to risk of damage to the coronary arteries. The ViewFlex™ X ICE Catheter Sensor Enabled™ is to be used only with the ViewFlex™ Catheter Interface Module and the ViewMate™ Multi ultrasound consoles. Any other use or inappropriate electrical connection may pose a serious risk to patient safety. The ViewFlex™ X ICE Catheter Sensor Enabled™ includes a 9 F shaft. The physician should consider anatomical size restrictions if considering use of the ViewFlex™ X ICE Catheter Sensor Enabled™. Do not use excessive force to advance or withdraw the catheter. Using excessive force can result in patient injury or death. Ensure that the two steering knobs are in the neutral position before advancing or withdrawing the catheter. If you encounter strong resistance during catheter articulation, discontinue the procedure. Identify and address the cause of the resistance before resuming the procedure. Withdraw and redirect the catheter as needed. Have antiarrhythmic drugs, an external defibrillator, and respiratory assist equipment available in case of complications during the use of this device. Catheter materials are not compatible with magnetic resonance imaging (MRI). Arrhythmia, bleeding, cardiac Perforation, cardiovascular injury, cerebrovascular injury, electric shock, embolism, immunological reaction, infection, myocardial ischemia, organ injury, peripheral vascular injury, respiratory compromise.
Indication for Use
The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
Contraindications
The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:
- With the presence of intracardiac thrombus.
- With active endocarditis or other infections producing bacteremia.
- Where placement of the device would interfere with any intracardiac or intravascular structures.
Potential Adverse Events
Potential adverse events associated with the device or implant procedure include, but are not limited to, the following: Air embolism; Airway trauma; Allergic reaction; Anemia; Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other); Arrhythmia; Atrial septal defect; Bleeding; Cardiac arrest; Cardiac tamponade; Chest pain/discomfort; Congestive heart failure; Death; Device embolization; Device erosion; Device malfunction; Device malposition; Device migration; Device-related thrombus; Fever; Hematuria; Hypertension/hypotension; Infection; Multi-organ failure; Myocardial infarction; Perforation; Pericardial effusion; Pleural effusion; Renal failure/dysfunction; Respiratory failure; Seizure; Significant residual flow; Stroke; Thrombocytopenia; Thromboembolism: peripheral and pulmonary; Thrombus formation; Transient ischemic attack; Valvular regurgitation/insufficiency; Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other); Vessel trauma/injury.
