A UNIQUE ALTERNATIVE

TO THERMAL ABLATION

 

The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue.

A UNIQUE ALTERNATIVE

TO THERMAL ABLATION

The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue.

Since being introduced to US market in 2007, the NanoKnife System has been used in over 5,450 procedures.

A NanoKnife* procedure is an ablation procedure that involves the delivery of a series of high voltage direct current electrical pulses between two electrodes placed within a target area of tissue. The electrical pulses produce an electric filed which induces elctroporation on cells within the target area. Electroporation is a technique in which an electrical field is applied to cells in order to increase the permeability of the cell membranes through the formation of nanoscale defects in the lipid bilayer.

After delivering a sufficient number of high voltage pulses, the cells surrounding the electrodes will be irreversibly damaged. This mechanism which causes permanent cell damage is referred to as Irreversible Electroporation (IRE).

The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

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.

Locate a Physician in Your Area

Enter a Zip Code to
begin your search.

 

The NanoKnife System has not received clearance for the therapy or treatment of any specific disease or condition.

Locate a Physician in Your Area

Enter a Zip Code to begin your search.

 

The NanoKnife System has not received clearance for the therapy or treatment of any specific disease or condition.

 

 

INDICATIONS FOR USE:

FDA: The NanoKnife is intended for the surgical ablation of soft tissue in the United States. The FDA has not cleared the NanoKnife System for the treatment of any specific disease state 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; Recent history of Myocardial Infarction.

POTENTIAL ADVERSE EFFECTS:

Adverse effects that may be associated with the use of the NanoKnife system include, but are not limited to the following: Arrhythmia; Pneumothorax; Muscle contraction; Hemorrhage; Unintended mechanical perforation; Infection; Bradycardia; Vagal Stimulation, asystole; and damage to critical anatomical structure (nerve, vessel, and/ or duct). Indications, contraindications, warnings, precautions and instructions for use can be found in the Instructions for Use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

Please refer to the NanoKnife System User Manual and the NanoKnife Single Electrode Probe Directions For Use for complete instructions, warnings and precautions.

*AngioDynamics, the AngioDynamics logo, NanoKnife and the NanoKnife logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2018 AngioDynamics, Inc.