Axonics files FDA premarket approval supplement for fourth-generation rechargeable neurostimulator

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Axonics has filed a premarket approval (PMA) supplement with the US Food and Drug Administration (FDA) for its fourth-generation rechargeable sacral neuromodulation (SNM) implantable neurostimulator, which is intended to treat bladder and bowel dysfunction.

The fourth-generation stimulation technology reduces how frequently a patient needs to recharge their implanted device to just once every six months for one hour, according to a company press release. This compares favourably to the current recharging interval of once a month for one hour with Axonics’ third-generation rechargeable stimulator.

This new stimulator utilises the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive, easy-to-use patient remote control. Axonics expects the new stimulator to receive FDA labelling for 20 years of useful life in the body, the release also details.

Axonics anticipates receiving FDA approval for the fourth-generation rechargeable implantable neurostimulator in the fourth quarter of 2022 and expects to begin shipping the new device to customers in the first quarter of 2023.

This filing follows the recent FDA approval of the Axonics F15—the company’s newly developed, long-lived, recharge-free system, which commenced a comprehensive US commercial launch in April.


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