Plymouth based Urotronic receives license to begin treating urethral strictures with its innovative Optilume drug-coated balloon (DCB) in Canada. The development is expected to have a significant impact across Canada where just a handful of physicians currently perform the majority of all stricture treatments.
“We are quite excited to see this come to market,” says Dr. Conrad Maciejewski, a reconstructive urologist who treats patients at The Ottawa Hospital and is one of just 9 doctors in Canada who practice in the field of reconstructive urology.
Millions of men around the world suffer from incapacitating urethral strictures. The condition blocks 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. The number of urological procedures is growing rapidly due to a growing elderly population and are more susceptible to urinary tract problems.
Urortonic’s innovative device called Optilume combines balloon dilation with the delivery of an anti-proliferative drug to prevent recurrence of the blockage. In clinical trials performed 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 says there is a significant need for new and alternative urethral stricture treatments. Most of his patients would prefer to avoid major reconstructive surgery called urethroplasty and are also not satisfied with the 40 per cent success rate of a common endoscopic intervention known as an urethrotomy. “This is the first time we’ve had a product that can significantly exceed those success rates with better durability and potentially less side effects compared to a major surgery,” he says.
“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.” says David Perry, president and CEO of Urotronic. Urologists across Canada, many whom will be attending the upcoming Canadian Urological Association (CUA) conference in Halifax, Nova Scotia, are also encouraged by the potential of Optilume™. The device has the potential to lift the burdens of the current Canadian market by adopting a treatment that is easy to learn and can be performed in a short outpatient procedure.
“If we were able to offer, in the hands of general urologists or even specialists, something less invasive, more accessible and with better results than what our current less invasive options provide, that would be a great option and, I think, a lot of people would seriously consider it,” Dr. Maciejewski says.
A Canadian post-market trial is currently scheduled. The U.S. Food and Drug Administration also continues to monitor clinical trials involving the Optilume DCB in the United States.