FDA grants clearance to NanoKnife System for prostate tissue ablation

The FDA has granted 510(k) clearance to the NanoKnife System for use in prostate tissue ablation, AngioDynamics announced in a news release.¹

The PRESERVE trial enrolled 121 patients with intermediate-risk prostate cancer.

The NanoKnife System, which utilizes irreversible electroporation (IRE) technology, was previously approved in the US for use in soft tissue ablation. The current 510(k) clearance grants a more specific indication for ablation of prostate tumors.

“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, in the news release.¹ “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 clearance is supported by data from the PRESERVE trial (NCT04972097), which evaluated the safety and effectiveness of the NanoKnife System in ablating prostate tissue in patients with intermediate-risk prostate cancer. Overall, the PRESERVE trial met its primary efficacy end point by demonstrating a negative in-field biopsy rate of 84% at 12 months following treatment with the NanoKnife System.

Data from the trial also showed that short-term urinary continence was preserved following treatment, with a rate of 96.6% at baseline and 95.4% at 12 months. The ability to maintain erections sufficient for intercourse decreased from 80.7% at baseline to 71.7% at 12 months.

In total, the open-label trial enrolled 121 adult patients with intermediate-risk prostate cancer across 17 clinical trial sites in the US.²

To be eligible for enrollment, patients needed to be at least 50 years of age with histologically confirmed organ-confined prostate cancer staged T2c or lower and at least a 10-year life expectancy. Patients also had to have a Gleason score of 3+4 or 4+3 and a prostate-specific antigen (PSA) level of 15 ng/mL or lower or a PSA density lower than 0.2 ng/mL² if the PSA is greater 15 ng/mL. Additionally, patients could not have evidence of extraprostatic extension or seminal vesicle invasion by mpMRI.

For the study, all patients received IRE of the prostate with high voltage (2-3 kV) pulses lasting up to 100 microseconds through 2 to 6 monopolar probes.

The primary outcome efficacy end point was the rate of negative in-field biopsy at 12 months, and the primary safety end point was the incidence of adverse events (AEs) through 12 months. Secondary outcome measures included assessments of urinary and erectile function, changes in prostate volume, and pre- and post-operative quality of life.

“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 concluded in the news release.¹ “AngioDynamics is committed to driving meaningful impact through this revolutionary technology, providing new hope to patients and improved quality of life.”

References

1. AngioDynamics receives FDA clearance for the NanoKnife System for prostate tissue ablation. News release. AngioDynamics, Inc. Published online and accessed December 9, 2024. https://www.businesswire.com/news/home/20241209958174/en/AngioDynamics-Receives-FDA-Clearance-for-The-NanoKnife%C2%AE-System-for-Prostate-Tissue-Ablation

2. Pivotal study of the NanoKnife System for the ablation of prostate tissue (PRESERVE). ClinicalTrials.gov. Last updated August 4, 2023. Accessed December 9, 2024. https://clinicaltrials.gov/study/NCT04972097