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 FlexAbility™ Ablation Catheter, Sensor Enabled™, when used in conjunction with a compatible irrigation pump and compatible RF generator, is indicated for: Endocardial mapping, stimulation, and ablation for the treatment of typical atrial flutter. Endocardial or epicardial mapping, stimulation and ablation for the treatment of recurrent, drug-refractory, sustained monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease, when used in conjunction with a compatible cardiac mapping system. Contraindications: In patients with active systemic infection. In patients with intracardiac mural thrombus or those who have had a ventriculotomy or atriotomy within the preceding four weeks. In addition, the following contraindications apply for treatment of ventricular tachycardia: Patients who have had a ventriculotomy or atriotomy within the preceding four weeks as the recent surgery may increase the risk of perforation. Patients with prosthetic valves as the catheter may damage the prosthesis. The use in coronary arterial vasculature due to risk of damage to the coronary arterial vasculature. The transseptal approach 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 in patients who have had aortic valve replacement. Patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation. Warnings: Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long terms risks of RF ablation lesions have not been established. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped air can cause potential injury or fatality. Precautions: If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery should be manually discontinued. Always maintain constant irrigation to prevent coagulation within and around electrodes. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablation near electrically vulnerable, thin-walled or other arterial structures. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Reestablish irrigation flow prior to placing catheter in the body. Do not attempt ablation without using an irrigation pump. Potential adverse events: Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including inadvertent AV block.
MAT-2501113 v1.0
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