Indications, Safety, and Warnings

The Cardioblate CryoFlex Surgical Ablation System

Indications for Use

The Cardioblate^® CryoFlex™ Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7cm, 10cm, 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 Probe is not designed for use inside a beating heart.

Adverse Events or Complications

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

• Bleeding
• Re-operation
• Extension of extracorporeal bypass
• Heart rhythm disturbances (atrial and/or ventricular)
• 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

Avoid contact between the cryoablation probe and the phrenic nerve to avoid injury. Perioperative heart rhythm disturbances (atrial and/or ventricular)

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.

Caution

Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of all indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.

Cardioblate Surgical Ablation Monopolar Pens/MAPS

Indications for Use

The Cardioblate Surgical Ablation Monopolar Pens/MAPS are intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications

The Cardioblate Surgical Ablation Monopolar Pens/MAPS should not be used for

• Patients that have active endocarditis at the time of surgery

Potential Complications

Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are:

• Tissue perforation
• Extension of Extracorporeal bypass
• Perioperative heart rhythm disturbances (atrial and/or ventricular)
• Postoperative embolic complications
• Pericardial effusion or tamponade
• Injury to the great vessels
• Valve leaflet damage
• Conductions disturbances (SA/AV node)
• Acute ischemic myocardial event

Cardioblate BP2 (Bipolar Clamp)

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 the time of surgery
• Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown.

Potential Complications

Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are:

• Tissue perforation
• Extension of Extracorporeal bypass
• Perioperative heart rhythm disturbances (atrial and/or ventricular)
• Postoperative embolic complications
• Pericardial effusion or tamponade
• Injury to the great vessels
• Valve leaflet damage
• Conductions disturbances (SA/AV node)
• Acute ischemic myocardial event
• Thrombus formation

Cardioblate LP (Bipolar Clamp)

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 the time of surgery
• Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown.

Potential Complications

Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are:

• Tissue perforation
• Extension of Extracorporeal bypass
• Perioperative heart rhythm disturbances (atrial and/or ventricular)
• Postoperative embolic complications
• Pericardial effusion or tamponade
• Injury to the great vessels
• Valve leaflet damage
• Conductions disturbances (SA/AV node)
• Acute ischemic myocardial event
• Thrombus formation

Cardioblate 68000 Generator Surgical Ablation System Generator

To avoid the risk of electrical shock and/or burns to the patient, do not touch the patient while touching the outer housing or connections on the Cardioblate generator. Do not allow the patient to come into contact with the grounded metal surfaces during RF energy delivery.

Cardioblate Gemini Surgical Ablation Device

Indications for Use

The Cardioblate Gemini Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

Contraindications

The Cardioblate Gemini Surgical Ablation Device should not be used for

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

Potential Complications

Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are:

• Tissue perforation
• Extension of Extracorporeal bypass
• Perioperative heart rhythm disturbances (atrial and/or ventricular)
• Postoperative embolic complications
• Pericardial effusion or tamponade
• Injury to the great vessels
• Valve leaflet damage
• Conductions disturbances (SA/AV node)
• Acute ischemic myocardial event
• Thrombus formation

Cardioblate Navigator Tissue Dissector

Potential Complications:

Using excessive force when articulating may damage the distal links and/or cause unintended tissue damage