CryoConsole

Indications, Safety, and Warnings

Indications

Medtronic CryoCath Cryoablation system is comprised of cryoablation catheters and a CryoConsole. The Arctic Front Advance™ Cardiac CryoAblation Catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The Freezor^® MAX Cardiac CryoAblation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal atrial fibrillation in conjunction with the Arctic Front Advance Cryoballoon. Please read the specific product labeling indications for use before using the CryoAblation system.

Contraindications

Use of Arctic Front Advance Cryoballoon is contraindicated as follows:

• In the ventricle because of the danger of catheter entrapment in the chordae tendinae.
• In patients with active systemic infections.
• In conditions where the manipulation of the catheter within the heart would be unsafe (e.g. intracardiac mural thrombus).
• In patients with cryoglobulinemia.
• In patients with one or more pulmonary vein stents.

Use of Freezor MAX cryocatheter is contraindicated in patients with the following conditions:

• Active systemic infections
• Cryoglobulinemia
• Other conditions where the manipulation of the catheter would be unsafe (For example, intracardiac mural thrombus)

Warnings/Precautions

Do not re-sterilize the cryoablation catheters for purpose of reuse. Use only the appropriate size of the FlexCath^® Steerable Sheath with the cryoablation catheters because using another sheath may damage the catheter or balloon segment. 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 cryoablation catheter 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, as this may lead to tissue injury. 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. Placing 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, to avoid nerve injury. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed. The cryoablation (Arctic Front and Freezor MAX) catheters 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 that may be associated with cardiac catheterization and ablation listed alphabetically below include but are not limited to: 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; Fatigue; Fever; Headache; Hemoptysis Hypotension/hypertension; Lightheadedness; 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.

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.