The implantation of the first patient in the US comes following the approval from the US Food and Drug Administration in September.
Axonics Modulation Technologies (NASDAQ:AXNX) has announced that the first US-based patient has been implanted with its Axonics r-SNM System following clearance from the US Food and Drug Administration (FDA) in September.
As quoted in the press release:
Following the completion of customary post-approval regulatory activities, the first implant outside of a clinical study setting was conducted in California on October 29.
“This first patient was a perfect candidate for the Axonics device,” said Felicia Lane, M.D., Director of Urogynecology, Obstetrics and Gynecology, University of California, Irvine School of Medicine. “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. At UCI, we pride ourselves in providing our patients with the most effective and reliable treatments, and the Axonics system is a perfect example.”
The Axonics r-SNM System offers a long-lived miniaturized neurostimulator that is approximately the size of a USB stick and is qualified to operate for at least 15 years. Unlike some active implantable devices, the Axonics device can safely be left in place during full-body MRI scans.
The patient, Melissa Der Manouel, said, “The original implant gave me symptom relief and a new lease on life, but having to undergo surgery every few years was physically and emotionally taxing. When I learned about the small rechargeable Axonics device that will work for 15 or more years and is MRI compatible, it was the obvious choice. I’m grateful to have this opportunity to greatly improve my quality of life over the long term.”