The Nanoknife system experience
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IMPORTANT RISK INFORMATION 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/478 REV 01 10/2020 NanoKnife.com
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It is estimated 57,000 new cases of pancreatic cancer will be diagnosed in the U.S.
2020 Diagnosis
Surgery, Radition Therapy, and Chemotherapy are treatment options for pancreatic cancer but seldom produce a cure.
Current Treatment
On April 1st, 2019, AngioDynamics received FDA approval to Initiate the NanoKnife DIRECT Clinical Study for the treatment of stage III pancreatic cancer.
The DIRECT Study
The NanoKnife System utilizes its unique Irreversible Electroporation (IRE) technology to ablate, or destroy, cells.
The NanoKnife System
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1 Cancer Facts & Figures 2020. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdfAccessed February 26, 2020.
DIRECT is currently enrolling qualifying patients. You can contact our study support team to see if your patient qualifies at direct@angiodynamics.com.
Enrollment
DIRECT is led by Co-Principal Investigators – Govindarajan Narayanan, MD, Chief of Interventional Oncology at Miami Cancer Institute and Robert C.G. Martin, MD, PhD, Surgical Oncology at the University of Louisville.
Principal Investigators
The FDA approved study is composed of a Randomized Control Trial (RCT) and a real-world, controlled Registry. Each study arm contains approximately 260 patients.
Study Design
AngioDynamics launched the study to evalute the effects of their IRE platform, the NanoKnife System, on stage III pancreatic cancer.
Initiated by AngioDynamics
Want to learn a little more first? Visit our DIRECT Study website AngioDirect.com
Visit our Website
Too busy for phone? We understand. Send us an email to get in touch with our clinical team at direct@angiodynamics.com
Email Us
We have a dedicated study support phone line run by REAL people. Call us at +1 (800) 584-7608.
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See how Irreversible Electroporation Works
Does not rely on heat to achieve cell death
Spares critical structures
No Heat Sink Effect
Easy to use interface
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. IMPORTANT RISK INFORMATION 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/478 REV 01 10/2020 NanoKnife.com
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Touch Screen Display Intuitive software interface that streamlines procedure set-up and delivers real-time visual feedback, allowing for customization at every step of the ablation.
Easy User Input Keyboard and Trackpad for quick input
USB Port Easy export for procedural data
Connection Ports Connect up to 6 electrodes (min. of 2 needed)
Emergency Button Electrical Safety Button to stop power
Wheels Easily transported to and from the stroage location
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Cable Reach 10 ft. Connection cable
Access Insertion depth: 15 cm & 25 cm
Slim Profile 19 Gauge needle with trocar trip)
Adjustable Active probe tip: 0.5 cm - 4.0 cm
Markings Depth markers indicate depth to needle tip
Visibility Echogenic probe surface
The NanoKnife Generator
The NanoKnife Electrode
