CARDIAC ABLATION THERAPY
These Brief Statements are provided to explain Indications, Contraindications, Warnings/Precautions, and Potential Complications for Medtronic’s Cardiac Ablation therapy products.
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See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative or consult the Medtronic website at www.medtronic.com.
Brief Statement: Arctic Front Advance™ Cardiac CryoAblation Catheter
Indications
The Arctic Front Advance™ Cardiac CryoAblation Catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
Contraindications
Use of Arctic Front Advance™ cryoballoon is contraindicated 1) In the ventricle because of the danger of catheter entrapment in the chordae tendinae 2) In patients with one or more pulmonary vein stents, 3) In patients with cryoglobulinemia, 4) In patients with active systemic infections and 5) In conditions where the manipulation of the catheter within the heart would be unsafe (e.g. intracardiac mural thrombus).
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 radio frequency (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 Advance cryoballoon was 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; 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.
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 devices to sale by or on the order of a physician.
Achieve Mapping Catheter Models 990063-015/-020
Indications
The Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording or stimulation only. The Achieve Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.
Contraindications
The catheter is contraindicated as follows:
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For use as an ablation device
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For use with transseptal sheaths featuring side holes larger than 1.00 mm in diameter
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Retrograde approach
The catheter is contraindicated in patients with:
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An active systemic infection
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Left atrial thrombus
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Pulmonary vein stents
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Prosthetic heart valve (tissue or mechanical)
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Myxoma
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Interatrial baffle or patch
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Conditions where the manipulation of the catheter within the heart would be unsafe
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Acute myocardial infarction
See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.
Brief Statement: Freezor™ Max
Indications
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™ Cardiac CryoAblation Catheter for the following uses: 1) Gap cryoablation to complete electrical isolation of the pulmonary veins 2) Cryoablation of focal trigger sites and 3) Creation of ablation line between the inferior vena cava and the tricuspid valve.
Contraindications
Use of Freezor™ MAX cryocatheter is contraindicated in patients with active systemic infections, in patients with cryoglobulinemia and other conditions where the manipulation of the catheter would be unsafe (For example, intracardiac mural thrombus).
Warnings/Precautions
Do not re-sterilize this device for purpose of reuse. Do not connect the cryocatheter to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. Disconnect the catheter's electrical connection prior to defibrillation. 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. 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. Use adequate fluoroscopic visualization during a transaortic approach to avoid placing the ablation catheter within the coronary vasculature. 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. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. The Freezor MAX catheter was 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; 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.
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.
Brief Statement: CryoConsole
Indications
Medtronic CryoCath Cryoablation system is comprised of cryoablation catheters and a CryoConsole. The Arctic Front™ 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 Cryoballoon. Please read the specific product labeling indications for use before using the CryoAblation system.
Contraindications
Use of Arctic Front 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.
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.