Indications, Safety, and Warnings Ablation Products for Atrial Fibrillation


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 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. 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 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 device to sale by or on the order of a physician.

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Achieve Mapping Catheter

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:

  • For use as an ablation device
  • For use with transseptal sheaths featuring side holes larger than 1.00 mm in diameter
  • Retrograde approach

Electrophysiology studies are contraindicated when the patient’s underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death, as in the following conditions:

  • An active systemic infection
  • Left atrial thrombus
  • Pulmonary vein stents
  • Prosthetic heart valve (tissue or mechanical)
  • Myxoma
  • Interatrial baffle or patch
  • Conditions where the manipulation of the catheter within the heart would be unsafe
  • Acute myocardial infarction

Refer to the device 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.

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Achieve Advance Mapping Catheter

Indications

The Achieve Advance™ 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:

  • For use as an ablation device
  • For use with transseptal sheaths featuring side holes larger than 1.00 mm (0.04 in) in diameter
  • Retrograde approach

Electrophysiology studies are contraindicated when the patient’s underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death, as in the following conditions:

  • An active systemic infection
  • Left atrial thrombus
  • Pulmonary vein stents
  • Prosthetic heart valve (tissue or mechanical)
  • Myxoma
  • Interatrial baffle or patch
  • Conditions where the manipulation of the catheter within the heart would be unsafe
  • Acute myocardial infarction

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

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Freezor™ Cardiac Cryoablation Catheter

Indications

The 7 Fr Freezor Cardiac Cryoablation Catheter, CryoConsole System, and related accessories are indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT).

Contraindications

This device is contraindicated in patients with active systemic infection, where manipulation of the catheter would be unsafe (e.g., intracardiac mural thrombus) and in patients with cryoglobulinemia.

Warnings/Precautions

The impact of cryomapping with respect to patient outcomes has not been fully characterized. The Freezor Catheter contains a pressurized refrigerant during operation. Release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism. If an unanticipated event occurs, stop the procedure at any time by pushing the RED button on the console control panel. Do not pull on the Freezor Catheter, umbilicals, or CryoAblation Console while the catheter tip is frozen to the endocardial tissue, as this could lead to cardiac or vascular damage. Do not connect the Freezor Catheter to any radiofrequency generator or use the Freezor Catheter to deliver RF ablation energy, because this could cause catheter malfunction and/or patient harm. Do not resterilize or re-use any Freezor Catheter or sterile accessory under any circumstances. Freezor Catheters and sterile accessories are designed for single use only. Do not attempt to operate the 7 Fr Freezor Cardiac CryoAblation Catheter prior to reading and understanding the Instructions for Use.

Potential Complications

Potential complications that may be associated with cardiac catheterization and ablation listed alphabetically below include, but are not limited to: Access site complications including pain, hematoma, ecchymosis, infection, thrombosis or AV fistula; arrhythmias include new arrhythmias and/or worsening of existing arrhythmias; cardiac arrest and/or death; cardiac perforation with hemopericardium and/or tamponade; catheter entrapment in cardiac structures requiring surgical intervention; chest pain; coronary artery spasm/dissection/thrombosis; endocarditis; exposure to x-ray energy with possible cancer risk or harm to fetus; gas embolism with possible tissue infarction; heart block, partial or complete, potentially requiring implantation of a permanent pacemaker; hemorrhage; hemothorax; myocardial infarction; pericardial effusion; pericarditis or pericardial effusion; pleural effusion; pneumothorax; pseudoaneurysm; pulmonary edema; pulmonary embolism; stroke; thrombus, intravascular or intracardiac; thromboembolism with potential tissue infarction; transient ischemic attack; valvular damage; vasovagal reaction.

See the device manual for detailed information regarding the 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 these devices to sale by or on the order of a physician.

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Freezor™ Xtra Cardiac CryoAblation Catheter

Indications

The Freezor Xtra Cardiac Cryoablation Catheter, CryoConsole system, and related accessories are indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT). The Freezor Xtra catheter is also intended for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Freezor Xtra catheter freezes the target tissue and blocks the electrical conduction by creating an inflammatory response or cryonecrosis.

Contraindications

The Freezor Xtra Cardiac Cryoablation Catheter 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

The catheter contains pressurized refrigerant during operation. Release of this gas into the body or circulatory system due to equipment failure or misuse could result in gas embolism, pericardial tamponade, tissue emphysema, or other patient injury. Do not pull on the Freezor Xtra catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, as this may lead to tissue injury. Do not connect the Freezor Xtra catheter to a radiofrequency (RF) generator or use it to deliver RF ablation energy. Doing this may cause catheter malfunction or patient harm. Do not resterilize this catheter for purpose of reuse. This catheter is intended only to be used once for a single patient. Cryoablation involving coronary vessels with liquid nitrous oxide systems has been associated with subsequent clinically significant arterial stenosis. Care should be taken to minimize unnecessary contact with coronary vessels during cryoablation. Avoid positioning the catheter around the chordae tendineae, as this increases the likelihood of catheter entrapment within the heart, which may necessitate surgical intervention or repair of injured tissues. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue). The catheter may become trapped in the valve, damaging the valve and causing valvular insufficiency or premature failure of the prosthetic valve. Administer appropriate levels of peri-procedural anticoagulation therapy for patients undergoing endocardial right-sided procedures. Administer anticoagulation therapy before and after the procedure according to the hospital standards. Introducing any catheter into the circulatory system entails the risk of air or 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. Cryoablation procedures should be performed only in a fully equipped facility. This equipment should be used only by or under the supervision of physicians trained in surgical or endocardial cryoablation procedures. Do not attempt to operate the Freezor Xtra catheter prior to reading and understanding the Instructions for Use.

Potential Complications

Potential complications/adverse events associated with cardiac catheter cryoablation procedures include, but are not limited to, the following conditions: Access site complications (e.g., hematoma, infection, thrombosis, ecchymosis, AV fistula, bleeding from puncture site, hemorrhage), Arrhythmia (including new or worsening existing arrhythmias), Cardiac arrest, Cardiac tamponade/perforation, Catheter entrapment in cardiac structures requiring surgical intervention, Chest discomfort, pain or pressure, Coronary artery spasm, dissection, thrombosis, Damage to adjacent organs/structures, Death, Endocarditis, Heart block, partial or complete, potentially requiring permanent pacemaker, Hematoma, Hemothorax, Infection/sepsis, Myocardial infarction, Pericardial effusion, Pericarditis, Pleural effusion, Pneumothorax, Pseudoaneurysm, Pulmonary edema, Pulmonary embolism, Stroke/transient ischemic attack/embolism, Thrombosis, Valvular damage, Vascular complication (e.g., stenosis), Vasovagal reaction.

See the device manual for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Freezor MAX Cardiac Cryoablation Catheter

INDICATIONS

The FreezorTM 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™ 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 FreezorTM 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.

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CryoConsole Cardiac Cryoablation System

INDICATIONS

Medtronic Cryoablation system is comprised of cryoablation catheters and a CryoConsole. The Arctic FrontTM Advance Cardiac Cryoablation Catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The FreezorTM 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.

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.

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FlexCath Advance Steerable Sheath

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.

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