Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans
The Axonics r-SNM System is the only implantable SNM system that has
received full-body MRI conditional labeling for sale in
Full-body MRI labeling is a significant addition to the many differentiating attributes already offered by the Axonics r-SNM product: a miniaturized and long-lived implantable neurostimulator that is one-third the size of the only competitor and is qualified to last at least 15 years in the body. The Axonics r-SNM System also features, among other things, a fast and safe charging capability with an infrequent charging interval, and a patient-friendly wireless remote control.
“This is a game changer,” said
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 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
1 The Axonics r-SNM System is approved for sale in
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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