Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men.
The 200-patient pivotal trial is slated to start enrolling participants immediately.
“Physicians are looking for a technology that is minimally invasive and also curative,” principal investigator Dr. Sean Elliott said in prepared remarks. “The Optilume drug coated balloon has the potential to decrease the rate of recurrence and provide physicians and their patients better outcomes based on early clinical results.”
Preliminary results from the company’s first IDE trial show that the Optilume device improved symptom scores and urinary flow rates.
“Moreover, patient quality of life symptom scores significantly improved by 70% or higher at 3 6 and 12 months, peak urinary flow rates improved 17 ml/sec at 3 months with continuous improvement through 12 months,” co-principal investigator Dr. Ramon Virasoro said.
“We are honored to provide urologists and their patients a solution to prevent recurrence of urinary tract strictures with our Optilume drug-coated Balloon technology,” president & CEO David Perry added.