8 months ago
48 Affluent Medical, a French clinical-phase medtech company specialising in the development and industrialisation of medical prostheses, has announced the successful first-in-human implantation of Artus for the treatment of urinary incontinence in a patient as part of the European pilot study ‘Dry’.
This first implantation of the artificial urinary sphincter Artus was successfully performed by Prof. Roman Zachoval, MD, PhD, head of the Department of Urology at Thomayer University Hospital in Prague, Czech Republic, on a 68-years-old male patient with severe urinary incontinence. Also present was Prof. Nicolas Barry Delongchamps, urology professor at Cochin University Hospital in Paris, France, as surgical advisor of the clinical study of Affluent Medical.
Prof. Roman Zachoval, said: “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. 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.”
This first procedure lasted about 80 minutes and went according to plan. The device will be activated six weeks after implantation as soon as wound healing after surgery is complete.
Sébastien Ladet, CEO of Affluent Medical, added: “This first-in-human implantation of Artus is an important milestone for Affluent Medical. 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.”
Artus is an implantable artificial urinary sphincter developed for the treatment of moderate to severe urinary incontinence in both men and women. The device that controls the opening and closing of the patient’s urethra is activated by the patient via a remote control and has been designed to allow adaptation to the patient’s lifestyle.
Prof. Nicolas Barry Delongchamps said: “Artus is different from the current devices in three 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 personalised: 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.”
Urinary incontinence is a major public health problem worldwide. The pathology affects men and women alike at different stages of their lives. It is generally more prevalent among women than men, notably among younger patients (aged 25 and over) with disorders resulting from multiple child births or in older patients (40 and over) from prostate or bladder cancer treatments. Urinary incontinence has major impact on social life and mental health of patients, many of whom develop anxiety and depression disorders, as the pathology remains taboo for most sufferers.
An international study by the European Association of Urology (EAU) demonstrates the economic and environmental burden of urinary incontinence in the 27 countries of the European Union, in addition to the deteriorated quality of the lives of millions of patients waiting for a new innovative treatment solution. The costs calculated by the EAU in connection with urinary incontinence come to a total of €69 billion for 2023. These include the impact of incontinence on patient health, the costs of medical consultations and products such as adult diapers, incontinence-related absenteeism from work, admissions to nursing homes, and the environmental impact of care related to this condition. If no measures are taken, incontinence is poised to become a major health problem in Europe, exacerbated by an ageing population and resulting in a total economic burden of €320 billion in 2030.
