NanoKnife

Device-Type

Ablation System

Targated Speciality

Cryoablation

Manufacturer

Angiodynamics


Expanding the Boundaries of Ablation

The NanoKnife 3.0 System is expanding the boundaries of modern-day ablation. Its unique Irreversible Electroporation (IRE) technology does not rely on heat to achieve cell death. It uses a more natural method that destroys only targeted tissue, sparing critical structures including vessels, nerves and ducts.

With the NanoKnife 3.0 System comes an enhanced user experience– streamlining procedure set up and delivering real-time visual feedback.

Features and Benefits

PRECISION EMPOWERED.

The NanoKnife System gives a physician the ability to sculpt and control the ablation zone through a variety of electrode configurations. IRE effectively destroys the targeted tissue and gives you precise treatment margins resulting in confident treatment coverage for your procedure.


PRESERVATION REDEFINED.

The procedure spares vital structures by retaining the structural integrity of the targeted tissue. The delivery of non-thermal energy allows for the preservation of the extra-cellular matrix, facilitating post-ablation, histological and functional tissue regeneration.


VERSATILITY PERFECTED.

Multiple electrode configurations, coupled with a unique mechanism of action, allow the device to be used in all segments of an organ to optimize treatment delivery. Electrodes can be confidently placed near vital structures, maximizing your ability to personalize treatment to your patient’s anatomy.


PROPEL RESEARCH FORWARD.

AngioDynamics is sponsoring two key FDA-approved studies, DIRECT and PRESERVE.


The PRESERVE study, initiated by AngioDynamics, Inc. in partnership with SUO-CTC, will evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. It will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.

Safety informations

Indication For Use US:

The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue. 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 events

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

Device Documents

Related Device SKUs

* Select 2 or more (upto 4) SKUs to compare.
SKU Name Device SKUs Model International Part Number Description
NanoKnife 3.0
H78720300301US0 H787203003010 NanoKnife 3.0 Generator
NanoKnife 3.0
H787204001090 H787204001030 NanoKnife Single Electrode Activation Probe 15 cm
NanoKnife 3.0
H787204001100 H787204001050 NanoKnife Single Electrode Activation Probe 25 cm
NanoKnife 3.0
H787204003015 H787204003015 NanoKnife Single Electrode Probe Spacer
device-thumbnail
NanoKnife 3.0
  • Model : H78720300301US0
  • Procedure : -
  • International Part Number : H787203003010
  • Description : NanoKnife 3.0 Generator
device-thumbnail
NanoKnife 3.0
  • Model : H787204001090
  • Procedure : -
  • International Part Number : H787204001030
  • Description : NanoKnife Single Electrode Activation Probe 15 cm
device-thumbnail
NanoKnife 3.0
  • Model : H787204001100
  • Procedure : -
  • International Part Number : H787204001050
  • Description : NanoKnife Single Electrode Activation Probe 25 cm
device-thumbnail
NanoKnife 3.0
  • Model : H787204003015
  • Procedure : -
  • International Part Number : H787204003015
  • Description : NanoKnife Single Electrode Probe Spacer

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