AngioDynamics has secured FDA 510(k) clearance for its NanoKnife System for prostate tissue ablation, heralding a new option for men with intermediate-risk prostate cancer. The clearance, announced December 9, 2024, is based on the results of the pivotal PRESERVE clinical study, which demonstrated both the safety and effectiveness of the system. This milestone marks a significant step forward in function-preserving treatments for prostate tumors, potentially minimizing life-altering complications associated with traditional methods.
The PRESERVE study, conducted in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), enrolled 121 patients across 17 clinical sites. The study met its primary effectiveness endpoint, with 84.0% of men remaining free from in-field, clinically significant disease at 12 months post-procedure. Furthermore, the NanoKnife System exhibited strong quality of life outcomes, preserving short-term urinary continence (96.6% at baseline, 95.4% at 12 months) and only minimally decreasing the ability to maintain erections sufficient for intercourse (80.7% to 71.7%).
Irreversible Electroporation Technology
The NanoKnife System employs Irreversible Electroporation (IRE) technology, a non-thermal ablation method. It uses high-voltage pulses to create permanent nanopores in the cell membrane, leading to apoptotic-like cellular death in the targeted tissue. This approach allows for precise ablation of prostate tissue while preserving vital structures inside and outside the prostate.
Clinical Validation and Benefits
The PRESERVE study's results align with findings from over 32 clinical studies involving more than 2,600 patients worldwide, reinforcing the NanoKnife System's safety and clinical efficacy. According to AngioDynamics, the NanoKnife System offers an innovative alternative to conventional radical surgery or radiotherapy, which often results in significant dysfunction in urinary continence and erectile potency. The non-thermal approach is engineered to improve patient outcomes, reduce recovery times, and enhance quality of life.
The Need for Minimally Invasive Options
Prostate cancer is the second most common cancer in men globally, with approximately 1.5 million new cases diagnosed annually. Many patients seek alternatives to radical procedures that can lead to significant, long-term urological side effects. The NanoKnife System is the first and only non-thermal, radiation-free ablation technology designed to treat prostate tissue using IRE technology, offering patients a minimally invasive option for prostate treatment.
Company Statement
"We are incredibly proud to receive FDA clearance for the NanoKnife System’s use in prostate tissue," said Jim Clemmer, President and Chief Executive Officer 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."
