FDA Greenlights AngioDynamics’ NanoKnife Pilot Study

May 24, 2019

The FDA has given the all clear for AngioDynamics to initiate its NanoKnife pilot study for the ablation of prostate cancer tissue in low-risk patients.

The prospective, non-randomized pilot study is small-scale, spanning six patients across up to three clinical sites. It’s meant to help design a pivotal U.S. clinical study that will support a premarket approval application for treatment of prostate cancer.

NanoKnife is a minimally invasive technique that has used irreversible electroporation to successfully treat focal prostate lesions.

“This pilot study represents the next step in our comprehensive approach to establish NanoKnife as a platform technology to treat numerous cancers and conditions,” said Brent Boucher, AngioDynamics’ senior vice president and general manager of oncology.

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