The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental approval for 3T scans, the Axonics device continues to be the only SNM system available in the U.S. that is MRI-compatible for both 1.5T and 3T full-body scans, according to the company.
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 the company.
The 3T MRI approval came several months earlier than expected and follows a number of recent FDA approvals, including for a new wireless patient remote control with SmartMRI technology and Axonics’ next-generation implantable neurostimulator, which extends the interval between recharging to once per month.
“This FDA approval allows Axonics to provide healthcare professionals with more choices in selecting the optimal MR scanner for their patients’ imaging needs,” said Axonics CEO Raymond Cohen in a news release. “These approvals underscore Axonics’ commitment to providing best-in-class SNM solutions for patients, clinicians and the healthcare system.”
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.
Medtronic filed in October for FDA approval of its SureScan leads for full-body 1.5 and 3 Tesla MRI scanning. The leads are designed to work with Metronic’s recharge-free InterStim II system and rechargeable InterStim Micro system.
“We are confident about our submission to the FDA for our new InterStim portfolio and MRI technology,” the company said in a statement to MassDevice. “After 25 years of innovation in sacral neuromodulation (SNM) therapy in close partnership with physicians, and with the experience of over 325,000 treated patients, we understand that individual preferences, lifestyles and treatment goals affect therapy results. We’ve designed our upcoming new product portfolio with this in mind and are excited to help thousands more patients get their life back.”