Urotronic announced that HTX Urology is participating in an FDA-cleared study for a minimally invasive device for treating enlarged prostates.
Plymouth, Minn.-based Urotronic’s Optilume BPH (benign prostatic hyperplasia, otherwise known as enlarged prostate) catheter system is an outpatient procedure designed to combine balloon dilation to open the prostate and local drug delivery to maintain symptom relief. In contrast to other BPH procedures, there is no cutting, burning, steaming or use of lasers as nothing is left behind in the prostate, according to a news release.
Dr. R. Robert Dhir of HTX Urology in Webster, Texas, is set to use the Optilume BPH catheter system after a previous clinical study of 80 men who suffered from moderate-to-severe lower urinary tract symptoms caused by BPH found that patient quality of life symptom scores improved by more than 60% at the three-month mark and were sustained through two-year follow-up.
Investigators for the study with HTX Urology will monitor the progress of the current clinical trial, titled “Pinnacle,” which is now enrolling patients and following them for five years. The FDA is monitoring the progress of the trial for the investigational device as well.
“This is a promising solution for many of our patients,” Dhir said in the release. “They will benefit tremendously from its convenience and the fact it’s minimally invasive. There’s no other treatment option like it out there right now.”