Trial begins in Europe of Artus for stress urinary incontinence

The first patient has been implanted with the artificial urinary sphincter Artus for stress urinary incontinence as part of the European pilot study Dry, announced Affluent Medical, the developer of the device, in a news release.¹

Overall, the investigators plan to enroll 10 patients in the pilot study.

Implantation of the device was successfully performed by Roman Zachoval, MD, PhD, in a male patient with severe urinary incontinence. According to Affluent, the procedure took about 80 minutes and went according to plan. Assuming full recovery and wound healing of the patient, activation of the device will take place 6 weeks following implantation.

“Artus is easy to prepare and implant due to its innovative design compared [with] 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,“ said Zachoval, head of the department of urology at Thomayer University Hospital in Prague, Czech Republic, in the news release.¹ “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 5 days after the surgery with no complications.”

Overall, the investigators plan to enroll 10 patients in the pilot study. Completion of the Dry trial is anticipated for the second half of 2024.

“This first-in-human implantation of Artus is an important milestone for Affluent Medical. For the estimated 400 million individuals battling urinary incontinence, our innovative solution offers hope for improved quality of life,” said Affluent Medical CEO Sébastien Ladet, PhD, in the news release.¹ “In a next step, we will transition to the pivotal study to support market approval and start a trial to treat female patients.”

Artus is an artificial urinary sphincter for the treatment of patients with moderate to severe urinary incontinence. The device is designed to allow adaptation to a patient’s lifestyle via adjustments on cuff closure. Patients also activate the opening and closing of the urethra via a remote control.

“Artus is different from current devices in 3 essential ways. It is easy to implant. It is potentially safer for patients thanks to the ability to adjust the level of constraint, and therefore decrease the potential urethra’s erosion. Additionally, the use of Artus can be personalized. The patient can choose among several modes according to his or her activity, and the doctor can adjust the degree of tightening according to each patient’s need and the progression of the pathology. Finally, the device is so much easier to use for patients, thanks to the remote control,” said Nicolas Barry Delongchamps, MD, in the news release.1 Delongchamps, who was also present for the first implantationprocedure, is the surgical advisor of the trial and a professor of urology at Cochin University Hospital in Paris, France.

Validation of the implantation technique and functional performance of the Artus device took place in 2018.² For that study, the implant technique was verified by the temporary implantation of the Artus device in 3 female patients who were undergoing urogenital tract ablation via laparoscopy or open surgery. Implantation of the device via minimally invasive surgery was done in about 20 minutes. Surgical safety of the device was also verified, as well as the functional performance of the device in opening and closing the urethra.

References

1. Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence. News release. Affluent Medical. Published online and accessed March 12, 2024. https://www.affluentmedical.com/news/

2. Affluent Medical meets a major milestone with the first clinical trial of ARTUS. News release. November 5, 2018. Accessed March 12, 2024. https://www.affluentmedical.com/news/