Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System
The Axonics r-SNM System is already approved for head and neck MR scans
in
Cohen continued, “We met with the
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.
What is MRI Conditional Labeling
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
About
Axonics, based in
Forward-Looking Statements
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
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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
1 The Axonics r-SNM® System is an investigational medical device
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Source:
Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan
Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com
Investor
& Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com