AngioDynamics Earns FDA IDE for NanoKnife Feasibility Study in BPH

AngioDynamics received U.S. Food and Drug Administration (FDA) approval for its investigational device exemption (IDE) application to begin the RELIEF study.

RELIEF is a feasibility study assessing irreversible electroporation (IRE), the non-thermal ablation tech delivered by the company’s NanoKnife system, to treat lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). BPH can cause lower urinary tract symptoms, including urinary frequency, urgency, weak stream, and incomplete bladder emptying, that impair daily function and quality of life.

Current options for treatment vary from pharmacologic therapy to surgical interventions like transurethral resection of the prostate (TURP) and newer minimally invasive procedures. This highlights the need for further approaches that balance effectiveness with preservation of sexual and urinary function.

NanoKnife is cleared for surgical ablation of prostate tissue. AngioDynamics said in prior clinical experience with IRE in the prostate, physicians saw meaningful improvements in urinary symptoms associated with BPH in patients treated for intermediate-risk prostate disease. This observation offered clinical rationale for the RELIEF study.

The prospective, single-arm study will enroll 40 patients at up to five U.S. clinical sites. At six months post-treatment, patients will be evaluated for primary endpoints and followed for a total of five years for secondary endpoints. The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to six months post-procedure. The primary safety endpoint is the incidence and severity of device-related adverse events during that period.

In the RELIEF study, electrodes are placed transperineally into predefined treatment zones of the prostate under transrectal ultrasound guidance and general anesthesia. Treatment planning targets the transition zone bilaterally while preserving critical structures like the neurovascular bundles, external sphincter, and urethra.

In April, the company earned expanded European indications for NanoKnife to include soft tissue ablation for tumors of the liver, pancreas, kidney, and prostate, including in patients with intermediate-risk prostate cancer.

Comments from AngioDynamics and clinicians

Juan Carlos Serna, AngioDynamics senior VP, Scientific and Clinical Affairs: “The NanoKnife System has an established role in the treatment of men with intermediate-risk prostate disease. Physicians have consistently reported meaningful improvements in urinary symptoms following IRE with the NanoKnife System, a signal we believe warrants further clinical evaluation. 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.”

Felix Cheung, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer Center and RELIEF study leader: “The RELIEF study was designed with scientific rigor at its core. The study incorporates validated, well-established endpoints such as IPSS, uroflowmetry, and quality-of-life measures, alongside careful monitoring of sexual function and long-term durability through five years of follow-up. 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.”