On May 22, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that the United States Food and Drug Administration (FDA) approved the Company’s investigational device exemption (IDE) application for its NanoKnife Irreversible Electroporation pilot study for the ablation of prostate cancer tissue in low-risk patients (Press release, AngioDynamics, MAY 22, 2019, View Source [SID1234536531]).
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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 comprehensive 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 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.