Grenoble, France-based UroMems designed UroActive as a smart, automated artificial urinary sphincter (AUS) investigational device.
The company said in a news release that UroActive represents the first smart, automated AUS. Kicking off the clinical study marks a key step in its development, UroMems said.
UroMems believes the therapy could change the treatment of SUI and establish a new standard of care.
“This is a historic milestone for UroMems, patients, physicians and the industry as this is a first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women,” said Hamid Lamraoui, UroMems CEO and co-founder. “This is the next important step in delivering our novel technology to a large, underserved patient population with unmet needs not addressed by current options on the market.”
Dr. Emmanuel Chartier-Kastler, the principal investigator, performed the first male patient procedure at La Pitié-Salpêtrière University Hospital in Paris. The study holds approval from the National Agency for the Safety of Medicines and Health Products in France.
UroMems designed UroActive to utilize a MyoElectroMechanical System (MEMS). Placed around the urethral duct, the patient’s activity provides the basis for automatic device control. This eliminates the need for manual adjustments for the patient. As a result, UroMems said it provides improved ease of use and a better quality of life compared to current options.
“We see a high rate of today’s AUS implants that are revised or removed after three years,” said Dr. Daniel Elliott, a urologist at Mayo Clinic in Rochester, Minnesota, and clinical advisor to UroMems. “The potential of being able to personalize the therapy to the patient automatically, post-implantation is very appealing.”