Axonics® Submits PMA Supplement to FDA to Further Expand MRI Labeling
The FDA previously approved 1.5T and 3.0T MRI conditional labeling with head and full-body transmit coils for the implantable components of the Axonics r-SNM® System. This submission adds the ability to conduct MRI scans with detachable extremity transmit/receive coils. The standard FDA review timeline for labeling expansion PMA supplements is 180 days.
Extremity scans account for approximately 24% of all MRI scans performed today1. Axonics' current MRI labeling allows for extremity scans with RF body and specialized extremity coils. The expanded labeling would allow extremity scans using “Detachable Upper and Lower Extremity Transmit/Receive Coils.” The expanded labeling, if approved, would be applicable to all previously implanted Axonics Systems.
Guangqiang “Jay” Jiang, chief technology officer of Axonics, commented, “These additional conditions will provide Axonics with the widest range of MRI conditions in sacral neuromodulation. The benefits of this expansion include (a) better image quality for extremity scans and increased scanning setup flexibility; (b) broader MRI access for patients; and (c) avoiding RF exposure of the entire body, which may be important to patients who are frail, elderly, diabetic, obese, or pregnant as they are less tolerant to thermal stress from RF exposure. This submission further demonstrates Axonics’ commitment to continuous innovation for the benefit of patients, clinicians and the healthcare system.”
1 IMV Benchmark Report MR 2018
Axonics, based in
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the