*The EnSite™ X EP System has an open architecture which is capable of providing impedance based visualization for any catheter, which can be connected the the system via direct connection or with pins using the catheter input module.
- Reddy, V. Y., Gerstenfeld, E. P., Natale, A., Whang, W., Cuoco, F. A., Patel, C., ... & Mansour, M. (2023). Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. New England Journal of Medicine, 389(18), 1660-1671.
- Nair, D., Martinek, M., Colley, B. J., Sundaram, S., Hariharan, R., Morales, G., ... & Lo, M. (2023). Safety and effectiveness of the first contact force ablation catheter with a flexible tip. Heart Rhythm O2, 4(12), 784-793.
- Osorio, J., Hussein, A. A., Delaughter, M. C., Monir, G., Natale, A., Dukkipati, S., ... & Q-FFICIENCY Trial Investigators. (2023). Very high-power short-duration, temperature-controlled radiofrequency ablation in paroxysmal atrial fibrillation: the prospective multicenter Q-FFICIENCY trial. Clinical Electrophysiology, 9(4), 468-480.
- Verma, A., Haines, D. E., Boersma, L. V., Sood, N., Natale, A., Marchlinski, F. E., ... & PULSED AF Investigators. (2023). Pulsed field ablation for the treatment of atrial fibrillation: PULSED AF pivotal trial. Circulation,147(19), 1422-1432.
- Luani, B., Basho, M., Ismail, A., Rauwolf, T., Kaese, S., Tobli, N., ... & Genz, C. (2023). Catheter navigation by intracardiac echocardiography enables zero-fluoroscopy linear lesion formation and bidirectional CAVOTRICUSPID isthmus block in patients with typical atrial flutter. Cardiovascular Ultrasound, 21(1). https://doi.org/10.1186/s12947-023-00312-w
Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
United States: Required Safety Information
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. The use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion. 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. 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. Precautions: Ensure that surface electrodes, Patient Reference Sensors, and associated connectors do not contact one another, electrical ground, or metallic objects. EnSite™ X EP System components should be connected to power through an isolation transformer or the multiple socket outlet supplied with the system carts. Connecting equipment directly to a wall outlet may result in excessive leakage current. 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 in the presence of other magnetic fields. Do not drop the EnSite™ X EP System Field Frame or subject it to impact. Physical damage to the EnSite™ X EP System Field Frame may alter the EnSite™ X EP System Field Frame’s factory calibration.
Indications: The TactiFlex™ Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system. Contraindications: Do not use for any of the following conditions: recent ventriculotomy or atriotomy heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, transseptal approach with an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement; patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation. Warnings: The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Application of RF energy on the left atrial posterior wall exceeding 40 W in power, or use of contact force ≥15g, increases the risk of esophageal perforating complications including atrio-esophageal fistula and death. Application of RF energy outside of the power and duration recommendations may increase the likelihood of steam pop occurrence. Patients undergoing septal accessory pathway ablation are at risk for complete AV block which requires the implantation of a permanent pacemaker. Implantable pacemakers and implantable cardioverter/defibrillator (ICDs) may be adversely affected by RF current. The combination of intracoronary placement of the ablation catheter and RF energy application has been associated with myocardial infarction and death. Inspect tubing, connections, and saline irrigation for air bubbles prior to and throughout its use in the procedure. Air or bubbles in the saline irrigation may cause emboli, potential injury, or fatality. Increased contact force may increase the risk for perforation during manipulation of the catheter. Contact force in excess of 20 g may not significantly change the characteristics of lesion formation. Contact force accuracy above 50 g has not been established. Caution should be taken when placing lesions in the proximity of the specialized conduction system. To avoid thromboemboli, intravenous heparin should be used when entering the left heart during ablation. Always maintain a constant saline irrigation flow to prevent coagulation within the lumen of the catheter. When using the catheter with conventional EP lab system (using fluoroscopy to determine catheter tip location) or with a 3D navigational system, careful catheter manipulation must be performed, especially when used in combination with a long sheath, in order to avoid cardiac damage, perforation, or tamponade. Precautions: Always straighten the catheter tip before insertion or withdrawal. If irrigation flow is interrupted, immediately inspect and re flush the catheter outside of the patient. Re-establish irrigation flow prior to placing catheter in the body. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Be careful when ablating near electrically vulnerable, thin walled, or other arterial structures. Potential Adverse Events: Potential adverse events include, but are not limited to, cardiovascular related complications, including hematoma, pericardial effusion and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); tamponade; severe pulmonary vein stenosis; heart block; myocardial infarction; esophageal fistula, or death.
