Axonics previously received U.S. Food and Drug Administration approval for this INS and remote control last year. This version reduces how frequently a patient needs to recharge their sacral neuromodulation device to just once a month for about one hour. The newly approved remote control simplifies the process by which patients can receive a full-body MRI, avoiding the need for the patient to visit their implanting physician’s office.
“There has been a significant backlog of pending regulatory submissions in Europe due to Covid-19 and the transition to the new European Union Medical Device Regulation, which will become fully applicable later this month,” said Rinda K. Sama, chief operating officer of Axonics. “Despite the delay and investment of Axonics’ regulatory resources, we are committed to supporting our customers and delivering a superior therapy experience in all markets worldwide where Axonics has an established presence.”