AngioDynamics Receives FDA Approval to Initiate Pilot Study for the Use of NanoKnife® to Treat Prostate Cancer
The prospective, non-randomized pilot study includes six subjects at up
to three clinical sites. The pilot study is intended to inform the
design of a pivotal clinical study in
“On the heels of our first patient enrollment in our Stage III
pancreatic cancer IDE, we are excited to receive approval to conduct a
separate pilot IDE for the treatment of prostate cancer,” said
Prostate cancer is the second leading cause of cancer death in American men1. Approximately one man out of every nine will be diagnosed with prostate cancer during his lifetime1. Traditional treatment options have focused on standard whole-gland therapies, such as active surveillance, radical prostatectomy, and external beam radiation2. However, over the last decade, focal therapy has been evaluated as an alternative for select patients diagnosed with localized prostate cancer in order to minimize treatment-related toxicity2.
The NanoKnife® System is a unique, minimally invasive technique that has been used to successfully treat focal prostate lesions through irreversible electroporation.
About the NanoKnife System
The NanoKnife System has received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue. The NanoKnife System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores, or nano-scale defects, in the cell membranes result in cell death. The treated tissue is then removed by the body's natural processes over a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, the NanoKnife System does not achieve tissue ablation using thermal energy.
The NanoKnife System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery is hyperechoic and can be monitored under real-time ultrasound.
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1 Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
2 Giannarini, G., Gandaglia, G., Montorsi, F., & Briganti, A. (2014). Will Focal Therapy Remain Only an Attractive Illusion for the Primary Treatment of Prostate Cancer?