International Only - Not intended for physicians in the U. S. or Japan
Indications, Safety and Warnings
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.
Cardioblate® Gemini® Surgical Ablation Device
Indications: 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 (eg, through a purse string suture on a beating heart). Effects of this type of ablation are unknown.
Adverse Effects: 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, conduction disturbances (SA/AV node), acute ischemic myocardial event, thombus formation, nerve damage, unintentional burns, pericarditis, pleural effusion.
Cardioblate® MAPS Mapping, Ablation, Pacing, and Sensing Device
Indications: The Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Contraindications: The Cardioblate MAPS Mapping, Ablation, Pacing, and Sensing Device should not be used for patients that have active endocarditis at the time of surgery.
Adverse Effects: 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, conduction disturbances (SA/AV node), acute ischemic myocardial event, thombus formation, nerve damage, unintentional burns, pericarditis, pleural effusion, esophageal perforation.
