In contrast to some active implantable devices, the Axonics r-SNM System can be safely left in place during full-body MRI scans
Image: Axonics implants first US patient with its Axonics r-SNM System. Photo: Courtesy of VSRao from Pixabay.
Axonics Modulation Technologies, a US-based medical technology firm, has completed the first implantation of its Axonics r-SNM System in the US.
The company develops and commercialises advanced implantable rechargeable sacral neuromodulation (SNM) devices, and has implanted the first Axonics r-SNM System following the US Food & Drug Administration (FDA) approval for the device.
The medical devices manufacturer said that it has completed the customary post-approval regulatory activities and its first implant procedure, outside of a clinical study setting, was conducted in California.
Axonics chief medical officer Karen Noblett said: “In corporate announcements, we often talk about scientific and commercial milestones, but ultimately, helping patients like Ms. Der Manouel achieve tangible, long-term improvement in her bladder and bowel condition and quality of life is the most rewarding aspect of our work.
“We look forward to helping thousands of additional patients in the United States gain the same clinical, emotional and economic benefits that the Axonics r-SNM System provides.”
The US FDA has approved Axonics r-SNM System in September 2019
Sacral neuromodulation therapy is used to reduce urinary and bowel dysfunction symptoms and restore pelvic floor function, caused by a miscommunication between the bladder and the brain.
The Axonics r-SNM System, which is approximately the size of a USB stick, has been designed to offer a long-lived miniaturised neurostimulator and was approved to operate for at least 15 years.
The company said that in contrast to some active implantable devices, the Axonics r-SNM System can be safely left in place during full-body MRI scans.
In addition, the company has secured FDA approval to market the device in the US for the clinical indication of faecal incontinence, along with additional conditions under FDA review, including overactive bladder and urinary retention.
University of California Irvine school of medicine obstetrics and gynecology director Felicia Lane said: “This first patient was a perfect candidate for the Axonics device. Not only did our patient suffer with urinary and bowel dysfunction most of her adult life, her previously implanted SNM device required replacement due to battery depletion in less than four years.
“Just three short years after her second implant, the device failed due to a fractured lead wire requiring explantation of the entire system. We took this opportunity to implant the long-lived rechargeable system from Axonics which I consider to be state of the art in sacral neuromodulation.”