Closely-held Urotronic of Plymouth, MN has received a license to begin treating urethral strictures with its Optilume drug-coated balloon (DCB) catheter in Canada.
“We are quite excited to see this come to market,” Dr. Conrad Maciejewski, a reconstructive urologist who treats patients at The Ottawa Hospital and is one of only nine doctors in Canada who practice in the field of reconstructive urology, said in a statement.
Debilitating urethral strictures block the pathway for urine to exit the body from the bladder and can result in a painful, frustrating slowing of the urinary system. Strictures can be caused by infections, trauma and other medical procedures that injure the lining of the urethra.
Urortonic’s Optilume device combines balloon dilation with the delivery of an anti-proliferative drug to prevent recurrence of the blockage. In clinical trials in Latin America, the drug-coated balloon has performed as intended in both opening blockages and preventing the formation of scar tissue, which can develop quickly after any medical intervention.
Dr. Maciejewski said there is a significant need for new and alternative urethral stricture treatments. He said many of his patients would prefer to avoid major reconstructive surgery called urethroplasty and are also not satisfied with the 40% success rate of a common endoscopic intervention known as an urethrotomy.
“We are excited to introduce our innovative drug coated balloon to the Canadian market and look forward to working with physicians and their patients who suffer from this debilitating disease,” David Perry, president and CEO of Urotronic, said.
A Canadian post-market trial is currently scheduled. The FDA also continues to monitor clinical trials involving the Optilume DCB in the U.S.
