AngioDynamics’ NanoKnife Earns FDA OK for Prostate Tissue Ablation

AngioDynamics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NanoKnife system for prostate tissue ablation.

NanoKnife is a non-thermal, radiation-free ablation technology that’s designed to treat prostate tissue with IRE (Irreversible Electroporation) technology. This offers a minimally invasive option for prostate treatment.

It provides an alternative to conventional radical surgery or radiotherapy, which often causes significant dysfunction in urinary continence and erectile potency. The non-thermal approach was engineered to preserve vital structure inside and outside of the prostate.

This FDA clearance was achieved after completion of the company’s pivotal PRESERVE study and submission of results to the FDA in September. The study assessed the system for ablating prostate tissues in patients with intermediate-risk prostate cancer (PCa). PRESERVE enrolled 121 patients at 17 clinical sites.

The study met its primary effectiveness endpoint—at 12 months post-procedure, 84% of men were free from in-field, clinically significant disease. The study also showed strong quality of life outcomes, with short-term urinary continence preserved 96.6% at baseline and 95.4% at 12 months. The ability to maintain erections sufficient for intercourse only decreased 9% compared to baseline (80.7% to 71.7%).

“We are incredibly proud to receive FDA clearance for the NanoKnife System’s use in prostate tissue,” said Jim Clemmer, president and CEO of AngioDynamics. “This milestone is the first step in recognizing our vision to become the standard, function-preserving treatment for men with prostate tumors. The NanoKnife System minimizes the life-altering complications often associated with traditional treatments by selectively targeting prostate tissue while preserving critical functions. As we expand our global footprint and increase access to our technology, we are launching comprehensive education and awareness campaigns to empower physicians with hands-on training and clinical support while engaging patients through innovative outreach initiatives.”

The PRESERVE study results validated NanoKnife’s safety and clinical efficacy profile, reinforcing findings from over 32 clinical studies around the world involving more than 2,600 patients.

Clemmer added, “These efforts are designed to accelerate the adoption of the NanoKnife System, redefine the standard of care for prostate health, and deliver treatment outcomes that patients and physicians need. AngioDynamics is committed to driving meaningful impact through this revolutionary technology, providing new hope to patients and improved quality of life.”

In October, AngioDynamics launched a multicenter, multi-national trial (RECOVER-AV) to evaluate its AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in treating acute pulmonary embolism.