Indications, Safety, and Warnings
Indications
The Sphere-9 catheter is indicated for use in cardiac electrophysiological mapping (stimulation and electrogram recording) and for treatment of drug refractory, recurrent, symptomatic persistent atrial fibrillation (episode duration less than 1 year) and radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter when used with the Affera mapping system.
The Affera Integrated Mapping System is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system’s display screen.
Contraindications
Do not use this device under the following circumstances:
In patients with an active systemic infection.
In patients who have had cardiac surgery in the preceding eight weeks, as the risk of perforation may increase.
In patients with intracardiac thrombus or myxoma, as the catheter may precipitate an embolus.
In coronary vessels with diameter smaller than the expandable ablation electrode, as the catheter may damage the coronary vessels.
In patients with prosthetic valves, as the catheter may damage the prosthesis.
Using the transaortic retrograde approach in patients who have had aortic valve replacement.
Using the transseptal approach in patients with an interatrial baffle or patch, as the opening could persist and result in an iatrogenic atrial shunt.
Warnings and Precautions
Do not reuse, reprocess, or resterilize devices labeled single-use only. Only use with compatible devices listed in the instructions for use. The Integrated Affera Mapping System requires use of a set of proprietary localization patches to detect patient displacement and respiratory motion and deliver low energy patient auxiliary signals.
Treatment location should be confirmed using alternative techniques (e.g. fluoroscopy, intracardiac electrograms, intracardiac echocardiography) before treatment.
A connection to a compatible cardiac stimulator is allowed provided the stimulator is electrically isolated or physically disconnected when RF or PF energy is applied to the patient, outputs of the generator and stimulator must be isolated to prevent patient injury or damage to equipment.
The pacing functionality in the Affera Integrated Mapping System is not a life support device and is for diagnostic purposes only. Pacing may induce intentional or unintentional life-threatening cardiac arrhythmias.
Intravenous heparin must be used to reduce the likelihood of thromboemboli developing during the procedure. Patient injury may result from excessive delivery of fluids. Anticoagulation treatment should adhere to consensus guidelines,
Avoid steering the Sphere-9 catheter near other catheters to reduce the possibility of the catheters becoming entangled. Cardiac devices may be damaged by energy delivery. Catheter interactions with implantable leads may result in lead dislodgement or possible thrombus.
Cardiac ablation may induce intentional or unintentional life-threatening cardiac arrhythmias. RF therapy with the Sphere-9 catheter in patients who have a Biotronik ICD/CRT-D device may result in induction of ventricular tachycardia / ventricular fibrillation.
Care should be taken when ablating near sensitive structures (i.e., conduction system, coronary arteries) as unintended patient harm may occur. Catheter entrapment within the heart is a possible complication of cardiac ablation procedures that could necessitate surgical intervention.
The Affera Integrated Mapping and Ablation System has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. System operation may be temporarily interrupted if exposed to excessive external electromagnetic disturbance or electrostatic discharge.
Potential Adverse Events or Potential Complications
Arrhythmia, Atrioesophageal fistula, Cardiac perforation / tamponade, Cardiac or respiratory arrest, Conduction system injury, Coronary artery spasm / occlusion / stenosis, Damage / dislodgement to implantable leads, Damage / dysfunction of cardiac devices, Death, Embolism, Hemoptysis, Infection, Myocardial infarction, Phrenic nerve palsy / paralysis, Pulmonary edema, Pulmonary vein stenosis, Stroke, Valve damage, Vessel dissection
Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com .
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
US-SE-2500347 v2.0
