AngioDynamics has received FDA investigational device exemption (IDE) approval to begin the RELIEF feasibility study, evaluating its NanoKnife system for treating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
NanoKnife uses irreversible electroporation (IRE), a technology that delivers high-voltage electrical pulses to create permanent pores in cell membranes and destroy targeted tissue without thermal damage. The system is already FDA-cleared for prostate tissue ablation related to prostate cancer.
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The RELIEF study will enroll 40 patients across up to five U.S. sites and will assess safety and effectiveness, including changes in urinary symptoms using the International Prostate Symptom Score (IPSS).
AngioDynamics SVP Juan Carlos Serna said:
“The RELIEF study will generate the initial safety and effectiveness data needed to advance IRE as a tissue-sparing solution for the millions of men living with BPH.”
Dr. Felix Cheung, co-principal investigator, added:
“This thoughtful, methodical approach will generate the high-quality evidence needed to determine whether IRE can offer men with BPH/LUTS a non-resecting alternative with meaningful functional preservation.”
The study represents AngioDynamics’ effort to expand NanoKnife beyond cancer treatment into a less invasive approach for men with BPH.
