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.