Therapy Areas: Devices
Axonics Files PMA Supplement with FDA for Fourth Generation Rechargeable Neurostimulator
1 June 2022 - - US-based medical technology company Axonics, Inc. (NASDAQ: AXNX) has filed a premarket approval supplement with the FDA for its fourth generation rechargeable sacral neuromodulation implantable neurostimulator, the company said.

The fourth generation rechargeable INS reduces how frequently a patient needs to recharge their implanted device to only once every six months for one hour.

This compares to the current recharging interval of once a month for one hour with the Axonics third generation rechargeable INS.

The new INS utilizes 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 said it expects the new INS to receive FDA labeling for 20 years of useful life in the body.

Axonics anticipates receiving FDA approval for the fourth generation rechargeable INS in 4Q22 and expects to begin shipping the new device to customers in 1Q23.

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.

Based in Irvine, Calif., Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction.

Axonics' sacral neuromodulation systems provide patients suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy.

In addition, the company's urethral bulking hydrogel, Bulkamid, provides symptom relief to women with stress urinary incontinence.