Sacral neuromodulation may not work for everyone, but Axonics is hoping to more accurately identify those who may indeed be good candidates for the technology.
The devicemaker has acquired a new system that’s aimed at improving the process of placing temporary neurostimulation (SNM) leads in the correct location near the sacral nerve, it announced Monday. Typically, before a patient is implanted with a sacral neuromodulation device to treat bladder dysfunction, they undergo a trial period known as a peripheral nerve evaluation (PNE), during which a lead is placed under the skin and connected to an external controller for a few days to determine whether the technique helps improve their incontinence symptoms.
According to Axonics, doctors often put the temporary leads in place during a simple, in-office procedure without relying on real-time imaging—which, though a faster and less expensive approach, may make placement less accurate, and therefore could impact the efficacy of the treatment.
The newly acquired lead placement solution is designed to improve that process. It combines a hardware tool and software solution that can help doctors identify the best possible location for the temporary lead within a patient’s unique anatomy, based on an analysis of a standard X-ray of the patient’s pelvis. The tool takes only minutes to use, according to Axonics, and can be slotted easily into existing clinical workflows.
Axonics acquired the hardware and software—comprising the assets of medtech startup Radian—from Intermed Labs, a self-described health tech-focused “innovation lab and startup studio.” Financial terms of the acquisition weren’t disclosed.
Radian’s system hasn’t yet been cleared by the FDA, but Axonics said in this week’s announcement that it expects the regulator to sign off on the technology by the middle of next year, after which it’ll begin commercializing the lead placement tool in the U.S.
“Since Axonics’ founding, our SNM development efforts have focused on enhancing the physician and patient experience,” CEO Raymond Cohen said in the company release. “We expect the Radian technology will improve patient comfort, increase physician confidence and SNM access, simplify the learning curve for physicians new to SNM and increase PNE trial success rates, which should ultimately result in more adults being treated with our life-changing SNM therapy.”
Radian’s tech rounds out Axonics’ sacral neuromodulation portfolio, which already comprises a handful of neurostim implants. Its latest additions have focused on longevity: In January of this year, Axonics secured FDA clearance for the new and improved R20 device, which, as the name suggests, is a rechargeable implant that can be used for at least 20 years.
That regulatory nod was the second in less than a year for the company. Last March, it snagged the FDA’s sign-off for the F15 device, which doesn’t need to be recharged throughout its 15-year lifespan—and which can potentially last up to 20 years if energy-saving settings are used, according to its maker.