Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Summary

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Timeline

Start

2017-12-19

Primary completion

2019-06-04

Completion

2024-05-25

Publications

• Pichardo M, Rijo E, Espino G, Lay RR, Estrella R, Gonzalez C, Fernandez M, Soriano D, Peralta IM, Kaplan SA. Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. World J Urol. 2023 Aug;41(8):2209-2215. doi: 10.1007/s00345-023-04473-1. Epub 2023 Jun 24.

Drugs

Indications