1124-004 rA Optilume BPH Catheter System IFU (US)

Optilume® BPH is owned by Urotronic, Inc.

CAUTION: Investigational Device. Limited by Federal (United States) law to investigational use. Pending US FDA Pre-Market Approval. Approved for sale in Canada

1. Kaplan SA. AM23-3925. The PINNACLE Trial: 12-Month Report from a Randomized, Double-blind, Sham Controlled Study. 38th Annual EAU Congress, March 11, 2023. Milan, Italy. 2. Roehrborn CG, Gange SN, Shore ND, et al. The Prostatic Urethral Lift for the Treatment of Lower Urinary Tract Symptoms Associated with Prostate Enlargement Due to Benign Prostatic Hyperplasia: The L.I.F.T. Study. J Urol 2013;190:2161-7. 3. McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016;195:1529-38. 4. Chughtai B, Elterman D, Shore N, et al. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology 2021;153:270-6. 5. Urotronic clinical data on file.

Contact Us

2495 Xenium Lane North
Plymouth, MN 55441 USA
763.285.7496
optilumebph@urotronic.com

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