Axonics® Announces First Patient Implants in Canada With New Recharge-Free Sacral Neuromodulation System
08 September 2022 - 08:00PM
Business Wire
Axonics, Inc. (Nasdaq: AXNX), a global medical technology
company that is developing and commercializing novel products for
the treatment of bladder and bowel dysfunction, today announced the
first patient implants in Canada with the Axonics F15™, the
company’s newly developed, long-lived, fully recharge-free sacral
neuromodulation (SNM) system.
The University of Alberta implanted four patients this week with
the Axonics F15. The four patients were programmed at stimulation
amplitudes between 0.95mA and 0.30mA, resulting in an expected
battery longevity in the body ranging from 18 years to over 22
years.
The Axonics F15 received regulatory approval from Health Canada
following U.S. FDA approval. The comprehensive U.S. commercial
launch of the Axonics F15 commenced in the second quarter of
2022.
“The approval of the Axonics recharge-free system is welcome
news for patients in Canada suffering from bladder and bowel
dysfunction,” said Gary J. Gray, M.D., FRCS, a urologist and
clinical professor at the Kipnes Urology Centre in the Department
of Surgery at the University of Alberta. “I am excited to now offer
patients a recharge-free option that significantly increases device
longevity in the body alongside the rechargeable Axonics SNM system
that has helped so many of my patients.”
Karen Noblett, M.D., FPMRS, chief medical officer of Axonics,
said, “Millions of adults in North America suffer from incontinence
and struggle to find long-term symptom relief. SNM began
experiencing a renaissance a few years ago when Axonics introduced
the world’s first long-lived, miniaturized, full-body MRI
compatible, rechargeable SNM system. Similarly, our long-lived,
fully recharge-free SNM system has the potential to increase
adoption of SNM therapy and significantly improve the quality of
life for adults with bladder and bowel dysfunction.”
About the Axonics F15 SNM system
The Axonics F15 SNM system utilizes a recharge-free implantable
neurostimulator (INS) that is relatively small and thin at only 10
cubic centimeters in volume. The INS employs a primary cell battery
and has an expected life in the body of over 15 years at typical
stimulation parameters and over 20 years at lower energy settings.
Constant current stimulation allows the device to automatically
adjust the magnitude of stimulation to maintain symptom relief with
minimal reprogramming. The F15 is MRI compatible with 1.5 and 3.0T
whole-body MRI scanners and utilizes an intuitive, easy to use
recharge-free patient remote control.
About Axonics
Based in Irvine, Calif., Axonics is a global medical technology
company that is developing and commercializing novel products for
adults with bladder and bowel dysfunction. Axonics recently ranked
No. 1 on the 2021 Deloitte Technology Fast 500™ and the 2022
Financial Times ranking of the 500 fastest growing companies in the
Americas.
Axonics sacral neuromodulation (SNM) systems provide patients
suffering from overactive bladder and/or fecal incontinence with
long-lived, easy to use, safe, clinically effective therapy. In
addition, the company’s best-in-class urethral bulking hydrogel,
Bulkamid®, provides safe and durable symptom relief to women with
stress urinary incontinence (SUI). Overactive bladder affects an
estimated 87 million adults in the U.S. and Europe, with an
additional 40 million adults estimated to suffer from fecal
incontinence. SUI affects an estimated 29 million women in the U.S.
alone. Axonics’ clinically proven products are offered at hundreds
of medical centers across the U.S. and abroad. Reimbursement
coverage is well established in the U.S. and is a covered service
in most European countries. For more information, visit
www.axonics.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20220908005376/en/
Neil Bhalodkar 949-336-5293 ir@axonics.com
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