The FDA has expanded the use of a drug-coated balloon developed by Urotronic for male urinary procedures, which the company describes as one of the first of a new generation of devices in the space.
The paclitaxel-laden Optilume received the green light to help treat benign prostatic hyperplasia, better known as BPH. The double-balloon catheter was previously approved in late 2021 for use in reopening urinary strictures.
The device inflates and expands across two sections to mechanically widen the urinary tract and help relieve the difficult symptoms that come with a swelling prostate while delivering a local dose of paclitaxel to help maintain the pathway during healing.
The approval comes as the FDA lifts its previous warnings over a separate category of paclitaxel-coated balloons and stents. Though designed for use in blood vessels and the treatment of peripheral artery disease, their addition of the chemotherapy paclitaxel similarly aims to keep a reopened channel from swiftly reclosing.
While a previous small-scale analysis of clinical data had pointed toward the potential for earlier deaths with the cardiovascular devices, the agency said last week it was unable to replicate that finding across several larger studies.
According to Urotronic, the Optilume balloon’s use of paclitaxel shows functional improvements in urine flow that can be sustained through at least four years.
“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,” President and CEO David Perry said in the company’s announcement. “Drug-coated balloons are the future of interventional urology.”
Fashioned as a minimally invasive outpatient procedure, the Minnesota-based Urotronic’s expansion into BPH takes aim at a condition that the company estimates can affect as many as 70% of men between the ages of 60 and 69, and up to 80% of men over 70.
Urotronic presented clinical data from two studies earlier this year at the annual meeting of the American Urological Association in Chicago, claiming the device delivered “the highest sustained improvement in peak flow” after one year among minimally invasive surgeries.
Other device-based approaches to BPH have also taken a page from cardiovascular interventions. In 2021, Olympus acquired the developer of an in-office procedure utilizing a temporary stent, which expands the urinary tract and is removed after a few days.
Elsewhere in more-invasive approaches, Procept Biorobotics employs a water-based procedure it dubs Aquablation to help remove obstructive prostate tissue, while Boston Scientific acquired NxThera in 2018 for its radiofrequency-powered BPH ablation device.