Post on 09-Jul-2020
StimRouter Neuromodulation Therapy For Overactive Bladder
HELP YOUR PATIENTS,REDUCE THEIR URGE
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TARGET URGE SIGNALS AT THE TIBIAL NERVE
The StimRouter® Neuromodulation System for Overactive Bladder offers a permanent treatment
option for patients suffering from overactive bladder from urge incontinence.
Clinical Study Results: SAFETY, EFFICACY, AND QUALITY OF LIFETibial Nerve Stimulation has Level 1 evidence to support its safety and
efficacy for use in treating overactive bladder from urge incontinence.
A meta-analysis performed by Ruan, et al, suggests “PTNS for the
treatment of OAB significantly reduces urinary frequency and improves
Quality of Life.” Key measurements include:
ADVANCED DESIGN DELIVERS SIMPLICITY
EPT and Electrode Patch:The External Pulse Transmitter (EPT) delivers energy through the electrode patch to power the implanted lead.
• Attaches (snaps) onto the disposable gel electrode patch
• Externally worn, low-profile design
• Rechargeable; can last multiple days on one charge
Patient Programmer:The patient programmer is a small, handheld device that wirelessly controls the EPT.
• Stores up to 8 custom stimulation programs
• Tracks compliance and usage
• Allows patients to monitor and manage their
stimulation programs and level of stimulation intensity
WHAT’S THE ADVANTAGE?
• A permanent treatment option via a one-time minimally invasive outpatient procedure.
• Targeted Relief blocks urge signals at the Tibial nerve without an invasive spinal cord implant.
• Patients control their own personalized incontinence therapy.
• No implanted pulse generator. The StimRouter pulse transmitter sticks to skin over the
implanted lead like a small bandage.
• Conditional MRI Safety to minimize restrictions on future diagnostic tests.
The Lead:The implanted lead delivers low-level electrical impulses directly to the Tibial Nerve. It is the only component of theStimRouter system that is implanted.
• Integrated three stimulating electrodes and a receiveron the thin, flexible, 15cm lead
• Integrated anchor designed to minimize lead migration.
EFFICACYPTNS is shown to significantly reduce average voids from
baseline to follow-up with only one therapeutic session per week:
2.8 fewer voids per 24 hours
3.2 fewer daytime voids
1.3 fewer nighttime voids
STIMROUTER V SACRAL NERVE STIMULATIONAdditional recent studies have shown that PTNS therapy also provides
patients with durable results so they can continue to enjoy their
improved quality of life long-term.2 StimRouter offers a permanently
implanted option to allow those suffering with OAB symptoms to enjoy
treatment at home as often as desired. No more weekly visits to a
doctor’s office for treatment, now treatment travels with you and is
available at the push of a button.
However, unlike other permanently implanted options like Sacral
Nerve Stimulators, StimRouter is a simple, minimally invasive
procedure performed under local anesthesia. There is no implanted
pulse generator and patients control their own treatment so they
can receive and turn off stimulation at their discretion.
QUALITY OF LIFENumerous measurements also show significant improvements in
Quality of Life when using PTNS compared to baseline.
• SF-36 shows average QoL improvement of 4.7 from baseline
• Incontinence specific QoL using Fisher's method reported significant improvement
• Meta data shows consistently significant improvements in QoL, regardless of measurement method used
HOW DOES IT WORK?
Target and block urge signals
at the Tibial Nerve.
QUICK AND EASY PROGRAMMING
StimRouter stimulation amplitude can be set up to 30mA with up to eight (8) custom stimulation programs set via the Clinician’s Programmer.
Programming Parameters:
• Frequency: up to 200 Hz
• Pulse width: up to 500 µs
• Amplitude: up to 30 mA
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StimRouter®, Bioness and the Bioness Logo® are trademarks of Bioness Inc. in the United States or other countries | www.bioness.comRx Only
© 2018 Bioness Inc.
Individual results vary. Patients are advised to consult with a qualified physician to determine if this product is right for them.
Important Safety Information and Risks: For Indications for Use, Contraindications, Warnings, Adverse Reactions, Precautions and other safety information please refer to www.stimrouter.com/risks (also available in the StimRouter Clinician’s Guide).
1. Ruan, J., Dahabreh, I., Ip, S., Ferzandi, T., Wong, J. (2011). Female Pelvic Med & Reconstr Surg 17:5 supplement 2.2. Heesakkers, J., van Breda, J., van Kerrebroeck, P., Digesu, A., Slneil, S. (2018). Bluewind Medical Renova System Long-Term Safety and Performance
in Treatment of Patients Diagnosed with Overactive Bladder (OAB).
THE STIMROUTER ADVANTAGE
• Minimally invasive outpatient procedure
• Minimizes surgical and post-surgical complications
• Minimize recovery time and scarring
• Minimizes costs compared to more invasive treatments
• Precisely targets urge signals at the tibial nerve
• Custom stimulation solution controlled by clinician and patient
• Proven, durable outcomes
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Bioness Europe B.V. Stationsweg 413331 LR Zwijndrecht, The NetherlandsTelephone: +31.78.625.6088 Email: international@nl.bioness.comWebsite: www.bioness.com
Bioness Inc.25103 Rye Canyon LoopValencia, CA 91355 USATelephone: 800.211.9136 or 661.362.4850Website: www.bioness.com
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