Indications: The Arctic Front and Arctic Front Advance Cardiac CryoAblation Catheter Systems are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
Contraindications: Use of either Arctic Front or Arctic Front Advance cryoballoons is contraindicated:
Warnings/Precautions: Do not re-sterilize this device for purpose of reuse.
Use only the 12 Fr FlexCath™ Steerable Sheath family with the Arctic Front Advance cryoballoon because using another sheath may damage the catheter or balloon segment.
Do not inflate the balloon inside the sheath. Always verify with fluoroscopy or by using the proximal shaft visual marker that the balloon is fully outside the sheath before inflation to avoid catheter damage.
Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary veins stenosis.
Do not connect the cryoballoon to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm.
The catheter contains pressurized refrigerant during operation; release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences.
Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism.
Do not pull on the catheter, sheath, umbilical cables or console while the catheter is frozen to the tissue; this may lead to tissue injury.
Do not advance the balloon beyond the guide wire to reduce the risk of tissue damage.
Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency or premature failure of the prosthetic valve.
Always inflate the balloon in the atrium then position it at the pulmonary vein ostium to avoid vascular injury.
Do not ablate in the tubular portion of the pulmonary vein. Use continuous phrenic nerve pacing throughout each cryoablation application in the right pulmonary veins. To avoid nerve injury, place a hand on the abdomen in the location of the diaphragm to assess for changes in the strength of the diaphragmatic contraction or loss of capture. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed.
The Arctic Front and Arctic Front Advance cryoballoons were not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility.
Potential Complications: Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Anemia; Anxiety; Atrial flutter; Back pain; Bleeding from puncture sites; Blurred vision; Bradycardia;Bronchitis; Bruising; Cardiac tamponade;Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Cough; Death; Diarrhea; Dizziness; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; Hemoptysis; Hypotension/Hypertension; Light headedness; Myocardial infarction; Nausea/vomiting; Nerve injury; Pericardial effusion; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Tachycardia; Transient ischemic attack; Urinary infection; Vasovagal reaction; Visual changes.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 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
The Arctic Front Advance™ Cardiac CyroAblation Catheter is indicated for the treatment of patients with atrial fibrillation.
Use of Arctic Front Advance™ Cardiac CyroAblation is contraindicated:
See the device manuals for detailed information regarding indications, contraindications, warnings, precautions, and potential adverse events.