EXPANDING THE BOUNDARIES
OF ABLATION

The NanoKnife 3.0 System

EXPANDING THE BOUNDARIES
OF ABLATION

The NanoKnife 3.0 System

The NanoKnife 3.0 System and its unique IRE technology is able to ablate while sparing critical structures.1,2,3,4

The NanoKnife System is an ablative device that uses IRE (Irreversible Electroporation) technology to achieve cell death. The advanced system does not rely on heat, but instead, it uses a more natural method that destroys only targeted tissue, sparing critical structures including vessels, nerves and ducts. Unlike thermal modalities, zones of IRE ablation are not deformed or decreased by proximity to blood vessels. 1,2,3,4

The NanoKnife 3.0 System comes with an enhanced user experience. The intuitive software interface streamlines procedure set-up and delivers real-time visual feedback, allowing for customization at every step of the ablation process.

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.

Click here to learn more about the IRE technology behind the NanoKnife System.

DIRECT is a clinical study, sponsored by AngioDynamics, Inc., evaluating the use of IRE technology as a potential treatment for stage III pancreatic cancer.* The FDA approved study is composed of a real-world, controlled Registry and an additional Randomized Control Trial (RCT). This innovative study is designed to provide the most complete form of evidence available to patients, clinicians, payors and regulators. The study is currently enrolling patients. To find out more, visit AngioDirect.com

* 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.

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References:

1 Maor E. et al., The effect of irreversible electroporation on blood vessels, Technol. Cancer Res. Treat. 6(4), 307–312 (2007).10.1177/153303460700600407.

2 Rubinsky, B., Onik, G., and Mikus, P., Irreversible electroporation: a new ablation modality–clinical implications. Technol. Cancer Res. Treat. 6, 37–48. (2007). doi: 10.1177/153303460700600106.

3 Onik G., Mikus P., and Rubinsky B., Irreversible electroporation: implications for prostate ablation, Technol. Cancer Res. Treat. 6(4), 295–300 (2007).10.1177/153303460700600405.

4 Lee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST., Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology 255:426–433. (2010). doi: 10.1148/radiol.10090337.

Product Literature:

NanoKnife 3.0 Brochure

INDICATION FOR USE: US: The NanoKnife System with six outputs is indicated for
surgical ablation of soft tissue.
INDICATION FOR USE: CE: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability.

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 • Atrial fibrillation or flutter • Bigeminy • Bradycardia • Heart block or atrioventricular block • Paroxysmal supraventricular tachycardia • Tachycardia o Reflex tachycardia o Ventricular tachycardia • Ventricular fibrillation • Damage to critical anatomical structure (nerve, vessel, and/or duct) • Fistula formation • Hematoma • Hemorrhage • Hemothorax • Infection • Pneumothorax • Reflex Hypertension • Unintended mechanical perforation • Vagal Stimulation, asystole • Venous Thrombosis

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

AngioDynamics, the AngioDynamics logo, NanoKnife and the NanoKnife logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2020 AngioDynamics, Inc. GL/ON/WP/115 REV 01 03/20

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