FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Greenlights AngioDynamics’ NanoKnife Pilot Study

May 28, 2019
A A

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.

View today's stories