Indications, Safety, and Warnings

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

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.