Ablation is the removal or destruction of body tissue. Other forms of ablation include microwave, radiofrequency and cryoablation. The NanoKnife System is similar in that it destroys soft tissue in the body, but it achieves the ablation through alternative modalities.
The NanoKnife System is used in open, laparoscopic and percutaneous procedures. The percutaneous approach is depicted here.
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The NanoKnife System has not received clearance for the therapy or treatment of any specific disease or condition.
CONTRAINDICATIONS:Ablation procedures using the NanoKnife System are contraindicated in the following cases: ablation of lesions in the thoracic area in the presence of implanted cardiac pacemakers or defibrillators; ablation of lesions in the vicinity of implanted electronic devices or implanted devices with metal parts; ablation of lesions of the eyes, including the eyelids; patient history of Epilepsy or Cardiac Arrhythmia; and recent history of Myocardial Infarction.
WARNINGS AND PRECAUTIONS: CAUTION: Adverse effects that may be associated with the use of the NanoKnife system include, but are not limited to the following: arrhythmia, atrial fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, damage to critical anatomical structure (nerve, vessel, and/or duct), fistula formation, hematoma, hemorrhage, hemothorax, infection, muscle contraction, pneumothorax, reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis.