Cardioblate CryoFlex

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 7-cm, 10-cm, and 10-S probes plus the CryoFlex Clamp and CryoFlex Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Contraindications

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

Adverse Events or Complications

Potential adverse effects 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); 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; and death.

Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether cryoablation with the 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.