Affluent Medical today announced the successful first-in-human implant of its minimally invasive urinary incontinence treatment device.
Dr. Roman Zachoval completed the first implant of Artus, an artificial urinary sphincter. Zachoval, head of urology at Thomayer University Hospital in Prague, implanted Artus in a 68-year-old male patient with severe urinary incontinence.
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The procedure lasted about 80 minutes and went according to plan, according to a news release. Affluent Medical plans to activate the device six weeks after implantation, after the surgical wound healing process.
“Artus is easy to prepare and implant due to its innovative design compared to the previous generation of urinary sphincters. With the positioning of the cuff around the urethra and the implantation of the control unit the different steps of the implantation were straightforward,” Zachoval said. “We performed successful communication tests between the control unit and the remote control at the end of the surgery. The patient is doing well and was discharged five days after the surgery with no complications.”
Affluent Medical designed Artus to treat moderate-to-severe urinary incontinence in both men and women. Patients with the implant can activate the device with a remote control. It then controls the opening and closing of the patient’s urethra, enabling personalized therapy.
“This first-in-human implantation of Artus is an important milestone for Affluent Medical,” CEO Sébastien Ladet said. “With an estimated 400 million people suffering from urinary incontinence, this is hope of a better life thanks to our innovative solution. We intend to treat ten men as part of our pilot study ‘Dry’ and we expect completion in H2 2024. In a next step, we will transition to the pivotal study to support market approval and start a trial to treat female patients.”
