Axonics has announced the FDA approval of its next-generation rechargeable implantable neurostimulator for its r-SNM system under a premarket approval (PMA) supplement.
This next-generation implantable neurostimulator decreases how frequently a patient needs to recharge their implanted device to once a month for about one hour. This compares to the current recharging interval which is one hour every two weeks. This new feature will also give patients the option to customise their charging experience, for example, choosing to charge for only 15 minutes once a week or only one hour every two months for those patients at lower stimulation intensity levels. In addition to extending the recharging interval, the enhanced implantable neurostimulator will experience virtually no battery degradation over the 15+ year life of the neurostimulator due to the reduced charging burden.
The US FDA approved the long-lived, rechargeable, full-body MRI compatible Axonics r-SNM System in late 2019, with the first commercial sales occurring in November 2019. The next-generation Axonics implantable neurostimulator is expected to begin shipping to customers in the USA during the third quarter of 2020.