Competition in the sacral neuromodulation space continues to breed new options for patients with bladder and bowel dysfunction.
Irvine, CA-based Axonics now has FDA approval for its recharge-free sacral neuromodulation implantable neurostimulator, called F15. The approval comes on the heels of Medtronic winning FDA approval for InterStim X, the next generation of the company's InterStim portfolio's recharge-free device.
The Axonics F15 recharge-free sacral neuromodulation (SNM) implantable neurostimulator runs on a primary cell battery and is designed to last more than 15 years at typical stimulation parameters and more than 20 years at lower energy settings. The device is 20% smaller than Medtronic's InterStim X device, according to Axonics, and has MRI compatability. The F15 also comes with a recharge-free key fob freaturing the company's SmartMRI technology, and a proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses.
Mike Matson, a medtech analyst at Needham & Co., said the F15 approval closes a portfolio gap and could drive the next leg of sacral neuromodulation market share gains for Axonics.
“Axonics is keenly focused on developing innovative, best-in-class, patient-centric SNM solutions as well as expanding awareness and access to this life-changing therapy,” said Axonics CEO Raymond Cohen. “Our rechargeable system introduced innovations to the SNM category in late 2019 that clinicians and patients had been requesting for years – longevity in the body, full-body MRI compatibility, a miniaturized implant, fuss-free therapy and a patient remote control that is easy for patients to use. The new Axonics F15 recharge-free SNM system is similarly groundbreaking – a small and thin [implantable neurostimulator] with an expected life in the body of well over a decade that does not require any element of the system to be recharged – and sets a new standard for what is possible in this category. We expect to begin shipping the Axonics F15 system in April.”
Cohen said Axonics plans to launch a national television direct-to-consumer advertising campaign to increase awareness for the company's therapies.
"We remain confident that our commitment to innovation, quality and providing physicians and patients strong support will continue to drive market expansion and advance Axonics on its path to market leadership," he said.