Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA approval for a second-generation programmer for its r-SNM sacral neuromodulation system.
The Irvine, Calif.–based company’s new programmer is designed to program the Axonics external trial neurostimulator and the implantable neurostimulator in the procedure and post-operative environments, according to a news release.
The device is a touchscreen tablet that is supposed to offer a predictive programming algorithm to suggest how to program the patient’s therapy, a wireless system to reduce time during surgery, tools that facilitate lead placement and programming and exportable reports on SNM therapy performance and device usage.
“Axonics is committed to further enhancing our SNM product offerings to ensure physicians have the latest technology available to treat this underserved patient population and develop what we believe is a multi-billion-dollar market opportunity,” Axonics CEO Raymond Cohen said in the news release. “These innovations will further enable clinicians using the Axonics r-SNM system to identify optimal lead placement during the implant procedure and personalize therapy for each patient. FDA approval of the second-generation Programmer is part of an anticipated cadence of product enhancements in our robust product pipeline.”
Axonics’ r-SNM system won FDA pre-market approval in November for the treatment of overactive bladder and urinary retention, which followed the FDA approval that r-SNM won in September for fecal incontinence.
The implantable, rechargeable sacral neuromodulation device is touted as the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device approved for full-body MRI scans without needing the device explanted, according to a news release.
Axonics is currently involved in a legal battle over its SNM technology. In November, Medtronic (NYSE:MDT) filed a lawsuit against Axonics in the U.S. District Court for the Central District of California, alleging infringements of four patents for Medtronic’s SNM technologies indicated for bowel and bladder conditions.
Original Article: (https://www.massdevice.com/axonics-wins-fda-approval-for-enhanced-neurostimulator-programmer/)