INDICATIONS, SAFETY, AND WARNINGS Cardiac Ablation (Surgical)

CryoFlex Probes

Indications: The Cardioblate™ CryoFlex™ Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes plus the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Contraindications: The Cardioblate CryoFlex Surgical Ablation Probe is not designed for use inside a beating heart.

Adverse Effects: Potential adverse effects with this device are similar to other cardiac surgery procedures and may include the following:

  • Bleeding
  • Reoperation
  • Extension of extracorporeal bypass
  • Heart rhythm disturbances (atrial and/or ventricular)
  • Pericardial effusion
  • Pericarditis
  • Cardiac tamponade
  • Pleural effusion
  • Mediastinitis
  • Conduction disturbances (SA/AV node)
  • Acute ischemic myocardial event
  • Thrombus formation
  • Low cardiac output
  • Stroke
  • Renal, gastrointestinal, or respiratory complications
  • Sepsis
  • Adjacent structural damage
  • Death

Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during cryoablation.

CryoFlex Clamp and Probe

Indications: The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex Clamp and Surgical Ablation Probe and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Contraindications: The Cardioblate CryoFlex Clamp and Surgical Ablation Probe are not designed for use inside a beating heart.

Adverse Effects: Potential adverse effects with this device are similar to other cardiac surgery procedures and may include the following:

  • Bleeding
  • Reoperation
  • Extension of extracorporeal bypass
  • Heart rhythm disturbances (atrial and/or ventricular)
  • Pericardial effusion
  • Pericarditis
  • Cardiac tamponade
  • Pleural effusion
  • Mediastinitis
  • Conduction disturbances (SA/AV node)
  • Acute ischemic myocardial event
  • Thrombus formation
  • Low cardiac output
  • Stroke
  • Renal, gastrointestinal, or respiratory complications
  • Sepsis
  • Adjacent structural damage
  • Death

Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during cryoablation.

CryoFlex Console

Indications: The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes plus the Cardioblate CryoFlex Clamp and Cardioblate CryoFlex Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Contraindications: The Cardioblate CryoFlex Surgical Ablation Console, Clamps, and Probes are not designed for use inside a beating heart.

Adverse Effects: Potential adverse effects with this device are similar to other cardiac surgery procedures and may include the following:

  • Bleeding
  • Reoperation
  • Extension of extracorporeal bypass
  • Heart rhythm disturbances (atrial and/or ventricular)
  • Pericardial effusion
  • Ppericarditis
  • Cardiac tamponade
  • Pleural effusion
  • Mediastinitis
  • Conduction disturbances (SA/AV node)
  • Acute ischemic myocardial event
  • Thrombus formation
  • Low cardiac output
  • Stroke
  • Renal, gastrointestinal, or respiratory complications
  • Sepsis
  • Adjacent structural damage
  • Death

Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during cryoablation.

Cardioblate BP2

Indications for use: The Cardioblate BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications

The Cardioblate BP2 surgical ablation device should not be used for:

  • Patients that have active endocarditis at time of surgery
  • Ablation in a pool of blood (for example, through a purse string suture on a beating heart) (Effects of this type of ablation are unknown.)

Adverse effects

The following known adverse effects are associated with the use of the product:

  • Abrasion
  • Arrhythmia or EKG/ECG changes
  • Burn
  • Electrical shock
  • Infection
  • Ischemia
  • Organ dysfunction (cardiac)
  • Perforation
  • Tissue damage

The following are possible adverse effects related to the ablation of cardiac tissue in combination with open heart surgery:

  • Atrial lead dislodgement
  • Atrioesophageal fistula
  • Bleeding
  • Cardiac perforation/tamponade
  • Conduction disturbances (SA or AV node)
  • Esophageal injury
  • Extension of extracorporeal bypass
  • Major complication (death)
  • Mediastinitis
  • Myocardial infarction in the context of cardiac ablation
  • Pericarditis
  • Phrenic nerve paralysis
  • Pleural effusion
  • Pulmonary vein stenosis
  • Stroke or transient ischemic attack (TIA) post-ablation
  • Vagal nerve injury
  • Valve leaflet damage

Cardioblate LP

Indications for use: The Cardioblate LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications

The Cardioblate LP surgical ablation device should not be used for:

  • Patients that have active endocarditis at time of surgery
  • Ablation in a pool of blood (for example, through a purse string suture on a beating heart) (Effects of this type of ablation are unknown.)

Adverse effects

The following known adverse effects are associated with the use of the product:

  • Abrasion
  • Arrhythmia or EKG/ECG changes
  • Burn
  • Electrical shock
  • Infection
  • Ischemia
  • Organ dysfunction (cardiac)
  • Perforation
  • Tissue damage

The following are possible adverse effects related to the ablation of cardiac tissue in combination with open heart surgery:

  • Atrial lead dislodgement
  • Atrioesophageal fistula
  • Bleeding
  • Cardiac perforation/tamponade
  • Conduction disturbances (SA or AV node)
  • Esophageal injury
  • Extension of extracorporeal bypass
  • Major complication (death)
  • Mediastinitis
  • Myocardial infarction in the context of cardiac ablation
  • Pericarditis
  • Phrenic nerve paralysis
  • Pleural effusion
  • Pulmonary vein stenosis
  • Stroke or transient ischemic attack (TIA) post-ablation
  • Vagal nerve injury
  • Valve leaflet damage

Cardioblate Gemini-S

Indications for use: The Cardioblate Gemini-s surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

Contraindications: 

The Cardioblate Gemini-s surgical ablation device should not be used for:

  • Patients that have active endocarditis at time of surgery
  • Ablation in a pool of blood (for example, through a purse string suture on a beating heart) (Effects of this type of ablation are unknown.)

Adverse effects

The following known adverse effects are associated with the use of the product:

  • Abrasion
  • Arrhythmia or EKG/ECG changes
  • Burn
  • Electrical shock
  • Infection
  • Ischemia
  • Organ dysfunction (cardiac)
  • Perforation
  • Tissue damage

The following are possible adverse effects related to the ablation of cardiac tissue in combination with open heart surgery:

  • Atrial lead dislodgement
  • Atrioesophageal fistula
  • Bleeding
  • Cardiac perforation/tamponade
  • Conduction disturbances (SA or AV node)
  • Esophageal injury
  • Extension of extracorporeal bypass
  • Major complication (death)
  • Mediastinitis
  • Myocardial infarction in the context of cardiac ablation
  • Pericarditis
  • Phrenic nerve paralysis
  • Pleural effusion
  • Pulmonary vein stenosis
  • Stroke or transient ischemic attack (TIA) post-ablation
  • Vagal nerve injury
  • Valve leaflet damage

Cardioblate Pen

Indications for use: The Cardioblate surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications: The Cardioblate surgical ablation pen should not be used for patients that have active endocarditis at time of surgery.

Adverse effects

The following known adverse effects are associated with the use of the product:

  • Abrasion
  • Arrhythmia or EKG/ECG changes
  • Burn
  • Electrical shock
  • Infection
  • Ischemia
  • Organ dysfunction (cardiac)
  • Perforation
  • Tissue damage

The following are possible adverse effects related to the creation of spot or linear lesions in cardiac tissue in combination with open heart surgery:

  • Atrial lead dislodgement
  • Atrioesophageal fistula
  • Bleeding
  • Cardiac perforation/tamponade
  • Conduction disturbances (SA or AV node)
  • Esophageal injury
  • Extension of extracorporeal bypass
  • Major complication (death)
  • Mediastinitis
  • Myocardial infarction in the context of cardiac ablation
  • Pericarditis
  • Phrenic nerve paralysis
  • Pleural effusion
  • Pulmonary vein stenosis
  • Stroke or transient ischemic attack (TIA) post-ablation
  • Vagal nerve injury
  • Valve leaflet damage

Cardioblate XL Pen

Indications for use: The Cardioblate XL surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications: The Cardioblate XL surgical ablation pen should not be used for patients that have active endocarditis at time of surgery.

Adverse effects

The following known adverse effects are associated with the use of the product:

  • Abrasion
  • Arrhythmia or EKG/ECG changes
  • Burn
  • Electrical shock
  • Infection
  • Ischemia
  • Organ dysfunction (cardiac)
  • Perforation
  • Tissue damage

The following are possible adverse effects related to the creation of spot or linear lesions in cardiac tissue in combination with open heart surgery:

  • Atrial lead dislodgement
  • Atrioesophageal fistula
  • Bleeding
  • Cardiac perforation/tamponade
  • Conduction disturbances (SA or AV node)
  • Esophageal injury
  • Extension of extracorporeal bypass
  • Major complication (death)
  • Mediastinitis
  • Myocardial infarction in the context of cardiac ablation
  • Pericarditis
  • Phrenic nerve paralysis
  • Pleural effusion
  • Pulmonary vein stenosis
  • Stroke or transient ischemic attack (TIA) post-ablation
  • Vagal nerve injury
  • Valve leaflet damage

Important Safety Information: For a listing of indications, contraindications, precautions, warnings, and potential adverse effects, please refer to the Instructions for Use.

Valleylab FT10 Generator

Indications: The Valleylab™ FT10 Energy Platform is a high-frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

Contraindications: The cardiac tissue ablation feature is contraindicated for patients with active endocarditis at the time of surgery. Ablation in a pool of blood is contraindicated (for example, through a purse string suture).

Adverse Events:The potential adverse events related to the use of ablation systems include, but are not limited to, the following risks:

  • Abrasion
  • Arrhythmia
  • Burn
  • EKG/ECG changes
  • Electrical shock
  • Hemolytic anemia
  • Hypotension
  • Infection
  • Ischemia
  • Organ dysfunction
  • Perforation
  • Tingling

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