FDA Approves Use of Full-Body MRI for Pivotal Study Patients Implanted With Axonics System

Axonics Modulation Technologies Inc., a medical technology company focused on the development and commercialization of novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, announced the U.S. Food and Drug Administration (FDA) approved the use of full-body magnetic resonance imaging (MRI) using 1.5 Tesla MRI scanners for clinical study patients implanted with the Axonics System.
 
The approval was a result of a supplement filed by Axonics with the FDA under the Investigational Device Exemption (IDE) regarding the company’s ARTISAN-SNM 129-patient pivotal clinical study. The FDA concluded that Axonics provided sufficient data to support full-body MRIs.
 
Raymond W. Cohen, CEO of Axonics, commented, “Allowing full-body MRI scans for our clinical study patients means that none will have to undergo an explant of their neurostimulator device should they require an MRI. We view this as a very positive step by the FDA that underscores the quality of data that Axonics has submitted to the agency. Given this approval, we are confident that this capability will be included as part of the Axonics SNM System premarket approval (PMA) approval, which is anticipated in the second half of 2019.”
 
The Axonics System¹ is the first rechargeable SNM system approved for sale in Europe, Canada and Australia and is currently under PMA review by the FDA. Axonics offers a long-lived miniaturized neurostimulator that is approximately the size of a USB stick and is qualified to last at least 15 years in the body, as compared to the only competitive device on the market from Medtronic, which requires replacement every three to five years. The Axonics System also features many other differentiating attributes, including a patented tined lead, a wireless charging system optimized for infrequent charging, a key fob size easy-to-use patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming.
 
Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the United States and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established in the United States and is a covered service in Europe, Canada, and Australia.
 
Axonics, based in Irvine, Calif., develops and commercializes an implantable SNM system for patients with urinary and bowel dysfunction. The Axonics System is the first rechargeable sacral neuromodulation system approved for sale in Europe, Canada and Australia and the first SNM system to gain full-body MRI conditional labeling in Europe.

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¹ The Axonics r-SNM System is currently under PMA review and is designated as an investigational medical device