FDA Approves New Device for Enlarged Prostate Treatment
12 Jul 2023 • The US Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, i.e benign prostate hyperplasia (BPH). The Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.
Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties. The Optilume BPH System is a minimally invasive surgical therapy (MIST) consisting of a drug-coated (paclitaxel) balloon system. “Mechanical dilation with [the system] achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing,” said the makers of the device.
"There's nothing else like Optilume BPH that's currently available, it's the only treatment option that requires no cutting, burning, steaming, or implants," said Urotronic President and CEO David Perry in a press release.
Source: Urology Times | Read full story