AngioDynamics Receives FDA OK to Initiate Study for Use of NanoKnife in Prostate Cancer Treatment

AngioDynamics Inc., a provider of minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, announced that the U.S. Food and Drug Administration (FDA) approved its investigational device exemption (IDE) application for its NanoKnife Irreversible Electroporation pilot study for the ablation of prostate cancer tissue in low-risk patients.
 
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 the United States to support the approval of a future Premarket Approval Application (PMA).
 
“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 Brent Boucher, AngioDynamics senior vice president and general manager of Oncology. “This pilot study represents the next step in our approach to establish NanoKnife as a platform technology to treat numerous cancers and conditions.”
 
Prostate cancer is the second leading cause of cancer death in American men.¹ Approximately one man out of every nine will be diagnosed with prostate cancer during his lifetime.¹ Traditional treatment options have focused on standard whole-gland therapies, such as active surveillance, radical prostatectomy, and external beam radiation.² 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 toxicity.²
 
The NanoKnife System is a minimally invasive technique that has been used to successfully treat focal prostate lesions through irreversible electroporation.
 
AngioDynamics Inc. is a provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ product lines include ablation systems, fluid management systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products, and venous products.
 
The NanoKnife System has received FDA 510(k) clearance 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.

References
¹ Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed May 21, 2019.
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? Journal of Clinical Oncology, 1299-1301