FDA Approves AngioDynamics' IDE For RELIEF Study Testing NanoKnife In Benign Prostate Hyperplasia
(RTTNews) - AngioDynamics Inc. (ANGO), a medical technology company, on Wednesday reported that the U.S. Food and Drug Administration (FDA) approved an investigational device exemption (IDE) application, enabling the RELIEF study for the company's proprietary NanoKnife system in the treatment of lower urinary tract symptoms in male patients of benign prostatic hyperplasia.
Benign prostatic hyperplasia (BPH) is a prevalent urological condition, with an estimated 15 million men in the U.S. alone experiencing symptoms. The disease is generally treated by pharmaceutical or surgical interventions, such as the transurethral removal of the prostate (TURP). Common lower urinary tract symptoms (LUTS) associated with BPH include increased urinary frequency, urgency, weak stream, and incomplete bladder emptying.
NanoKnife constitutes a minimally invasive, non-thermal ablation technology called irreversible electroporation (IRE). The IRE uses short pulses of high voltage to create permanent nanopores in cell membranes, causing apoptotic cell death in the targeted tissue. The technology was previously granted an FDA 510(k) clearance in the targeted resection of the prostate and other soft tissue.
The RELIEF study is expected to enroll 40 patients of BPH subject to a six-month evaluation, and up to five years of follow-up. The therapy will involve the transperineal placement of electrodes into predefined treatment zones of the prostate under transrectal ultrasound guidance and general anesthesia. The treatment will aim electroporation toward affected tissue, while preserving essential structures of the urethra, external sphincter, and neurovascular bundles.
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.
ANGO closed Wednesday at $11.74, down 3.37%.
