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NanoKnife for Electric Execution of Tumors Gets FDA Approval for IDE Study

June 19th, 2013 Medgadget Editors Urology

NanoKnife-AngioDynamics
There are many methods clinicians use to attack tumors, including chemotherapy, gamma ray beams, and implantable radioactive particles. A new device soon to be trialed in the U.S. for precision ablation of prostate tumors is adding another weapon to the clinical arsenal. The NanoKnife from AngioDynamics (Queensbury, New York) does something called irreversible electroporation.  The technique involves setting up a very strong, but localized, electric field using a combination of electrodes. After a few quick bursts of energy, cell membranes within the target volume turn into proverbial Swiss cheese. This allows ions to enter the interior of the cells and leads to irreversible necrosis.

NanoKnife system

AngioDynamics, not yet having any FDA approved indications for the device, just got the green light to go ahead with an Investigational Device Exemption (IDE) trial of the NanoKnife for focal treatment of prostate cancer.

From the company:

The Company is moving forward with institutional review board (IRB) submissions and anticipates commencing patient enrollment in the Company’s fiscal 2014 second quarter, which ends November 30, 2013.

Separately, AngioDynamics has established a partnership with the Clinical Research Office of the Endourological Society (CROES) and is pursuing a study to establish evidence for the NanoKnife System’s position within the treatment armamentarium for low-intermediate localized prostate cancer. The study, “Multicenter Randomized Two-Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Unilateral Prostate Cancer,” will involve six European centers and 200 patients.

Flashback: Electrocuting Cancer Cells to Death with NanoKnife

Product page: NanoKnife System…

Press release: FDA Grants Prostate IDE Approval for AngioDynamics’ NanoKnife System

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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