The clearance follows the company’s completion of the pivotal PRESERVE clinical study, which enrolled 121 patients across 17 sites and was completed in collaboration with the Society of Urologic Oncology Clinical Trials Consortium.
According to the company, the study demonstrated the system’s safety and effectiveness, with 84% of patients free from clinically significant in-field disease at 12 months post-procedure. Additionally, the study reported favorable quality-of-life outcomes, including short-term urinary continence preservation and minimal reduction in erectile function.
“We are incredibly proud to receive FDA clearance for the NanoKnife system’s use in prostate tissue,” AngioDynamics President and CEO Jim Clemmer said in a news release. “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.”
More about the NanoKnife system
The NanoKnife system uses non-thermal, radiation-free irreversible electroporation (IRE) technology to ablate prostate tissue precisely. It offers clinicians and patients a minimally invasive alternative to traditional surgery or radiotherapy.
AngioDynamics said NanoKnife’s ablation approach aims to reduce recovery times and preserve urinary and sexual function. It also addresses some of the common concerns associated with prostate cancer treatments.
Prostate cancer is the second most common cancer in men globally, according to the company. There are 1.5 million cases diagnosed annually, and many patients seek alternatives to radical treatments that can cause significant long-term side effects.
AngioDynamics plans to support physicians’ adoption of the NanoKnife System through comprehensive training and education and other outreach initiatives to inform patients of their options.
“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,” Clemmer said. “AngioDynamics is committed to driving meaningful impact through this revolutionary technology, providing new hope to patients and improved quality of life.”
