Axonics Modulation Technologies, Inc. has announced the submission of complete test data to the U.S. Food & Drug Administration (“FDA”) for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging (“MRI”) labeling approval for the Axonics r-SNM® System1 for urinary and bowel dysfunction. This data was submitted as an amendment to the Company’s previously filed premarket approval application (“PMA”). Axonics Modulation Technologies, Inc. is 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.
Raymond W. Cohen, CEO of Axonics, commented, “Without this Full Body labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator and lead surgically explanted prior to the MRI scan, resulting in loss of an effective treatment, another surgery for the patient and additional cost to the patient and healthcare system. Our robust testing and analyses conclude that Full Body MRI scans can be safely performed on patients with an implanted Axonics r-SNM system.”
The Axonics r-SNM System is already approved for head and neck MR scans in Europe, Canada and Australia. CE Mark approval of Full Body MRI conditional labeling for the Axonics r-SNM System is currently pending.
Cohen continued, “We met with the FDA in January 2019 and determined it was advantageous to file an amendment to the current literature-based PMA. The FDA now has all of our MRI test data for both head and full body and we believe that, once PMA approved, our r-SNM System will include conditional labeling for 1.5T MRI scans.”
Axonics has performed all the required tests to support Full Body conditional labeling on 1.5T MR scanners for the implantable components of its r-SNM System.
Notes: MRI is short for Magnetic Resonance Imaging. MR scanners come in different magnet field strengths measured in Tesla or “T”, usually between 0.5T and 3.0T. They also come in varying sizes including open and wide-bore. Simplistically, an MR scanner is a very large, strong magnet into which a patient lies. A radio wave is used to send signals to the body of the patient. The returning signals are received and converted into images by a computer attached to the MR scanner. The image quality of an MRI depends on signal and field strength. MRI Conditional Labeling means a product has been tested and demonstrated to pose no known hazards to the patient in a specified MRI environment with specified conditions of use and the results of testing are sufficient to characterize the behavior of the product in the MRI environment. Testing for devices that may be placed in the MRI environment should address magnetically induced displacement force and torque, unintended stimulation, and thermal injury. Other possible safety issues include but are not limited to, image artifact, device vibration, interaction among devices, the safe functioning of the device and the safe operation of the MRI system. Any parameter that affects the safety of the device should be listed and any condition that is known to produce an unsafe consequence must be described.
About Overactive Bladder and Sacral Neuromodulation: Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the U.S. 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 a proven therapy to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established and available in the United States, Europe, Canada and Australia.