AngioDynamics has obtained an FDA green light for its NanoKnife prostate cancer ablation system, designed to precisely target and destroy tissue without delivering excess heat and the unintended thermal damage that may come with it.
The company’s radiation-free approach is similar to the pulsed field ablation technologies that have helped reshape cardiac ablation procedures for irregular heartbeats in the past year. NanoKnife delivers high-voltage bursts of electrical energy that causes small holes to form in cell membranes.
This leads to irreversible electroporation, where the membranes begin to collapse in a method akin to natural cell deaths. Using six separate needle-like probes, the ablation zone can be accurately sculpted, while the affected prostate tissue can be visualized in real-time under ultrasound.
“This milestone is the first step in recognizing our vision to become the standard, function-preserving treatment for men with prostate tumors,” AngioDynamics’ president and CEO, Jim Clemmer, said in a statement.
“The NanoKnife System minimizes the life-altering complications often associated with traditional treatments by selectively targeting prostate tissue while preserving critical functions,” Clemmer added. “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 FDA’s 510(k) clearance was based in part on the company’s pivotal PRESERVE study, conducted with the Society of Urologic Oncology Clinical Trials Consortium, which enrolled 121 patients with intermediate-risk prostate cancer—a category that includes about 40% of all newly diagnosed cases.
The trial met its primary performance endpoint, with 84% of men reporting no in-field, clinically significant disease after 12 months. At the same time, short-term urinary control was largely preserved, while the ability to maintain erections sufficient for intercourse decreased by 9% compared to baseline.
According to AngioDynamics, typical urological side effects following radical prostatectomy surgery include about one-third of men showing urinary leakage, and about 95% reporting erectile dysfunction lasting for years.
The NanoKnife system has also been approved in Canada and the European Union. Earlier this year, the FDA cleared a pulsed field, needle ablation system from Galvanize, for use against soft-tissue lesions including lung nodules suspected of harboring cancer.