US-based medical device company AngioDynamics has received the US Food and Drug Administration (FDA) 510(k) approval for its NanoKnife System for prostate tissue ablation.
The NanoKnife System leverages Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without using thermal energy.
It delivers high-voltage pulses that create permanent nanopores within the cell membrane, to induce an apoptotic-like cellular death that results in complete ablation of the targeted tissue.
According to AngioDynamics, NanoKnife provides an alternative to conventional radical surgery or radiotherapy, which often affects urinary continence and erectile potency.
Its non-thermal approach will preserve vital structures inside and outside the prostate, enabling improved outcomes, reduced recovery times, and enhanced quality of life.
AngioDynamics president and CEO Jim Clemmer said: “We are incredibly proud to receive FDA clearance for the NanoKnife System’s use in prostate tissue.
“This milestone is the first step in recognising our vision to become the standard, function-preserving treatment for men with prostate tumours.
“The NanoKnife System minimises 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 NanoKnife System was approved by the US FDA after the completion of the PRESERVE clinical study. The study results were submitted to the US FDA in September this year.
The study was conducted in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), which supports clinical trials in urologic oncology.
PRESERVE enrolled 121 patients across 17 clinical sites to assess the safety and efficacy of the system for ablating prostate tissue in patients with prostate cancer (PCa).
The study met its primary effectiveness endpoint validating the performance of the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa.
The system showed a safety and clinical efficacy profile in the PRESERVE study, which was consistent with findings from 32 clinical studies conducted worldwide, said AngioDynamics.
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.”
