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View of the Cardioblate™ Gemini™-s radiofrequency surgical ablation system on a transparent background

Indications, Safety, and WarningsIndications for useThe Cardioblate™ Gemini™-s 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.ContraindicationsThe Cardioblate™ Gemini™-s 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

Nerve damage

Unintentional burns

Pericarditis

Pleural effusion

Esophageal perforation

Death

Coronary sinus perforation

Coronary artery spasm

Atrial lead dislodgment

Hypotension

Pulmonary vein stenosis

Cerebrovascular accident

Transient ischemic attack

Blood loss

Caution: Federal law (United States) 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.UC202410025EN

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