Axonics (NSDQ:AXNX) announced that it filed a premarket approval supplement with the FDA for its sacral neuromodulation (SNM) system.
Irvine, Calif.-based Axonics filed the PMA supplement for its newly developed, long-lived, non-rechargeable SNM implantable neurostimulator (INS), according to a news release.
The company designed its new non-rechargeable SNM system to replicate the key features of its currently marketed and FDA-approved rechargeable SNM system. The new version includes a primary cell battery with an expected life of at least 10 years with standard constant-current stimulation parameters for longevity.
Axonics’ INS is 11 cubic centimeters and has compatibility with full-body MRIs with 1.5T and 3.0T scanners, while patients can remotely control it with an intuitive, recharge-free key fob featuring SmartMRI technology.
The company expects to begin shipping the new system to customers upon FDA approval, which is anticipated to come during the first half of 2022.
“Since the company’s founding, we have focused on developing best-in-class, patient-centric SNM solutions. Our rechargeable system introduced innovations to the SNM category that clinicians and patients had been requesting for years – longevity in the body, MRI compatibility, a miniaturized implant and a fuss-free patient remote control that is easy for patients to use,” Axonics CEO Raymond W. Cohen said in the release. “Our new non-rechargeable system is similarly groundbreaking – a relatively small and thin INS with an expected life in the body that is more than double the competitor’s non-rechargeable device. We are confident that the introduction of our non-rechargeable device will continue to drive market expansion and advance Axonics on its path to SNM market leadership.”