StimRouter Neuromodulation Therapy For Overactive Bladder

HELP YOUR PATIENTS,REDUCE THEIR URGE

®

02867_SR_hcp_OAB_brch_GLBL_r06v01.indd 1 12/17/18 4:26 PM

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

®

02867_SR_hcp_OAB_brch_GLBL_r06v01.indd 2-3 12/17/18 4:30 PM

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

02867

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

02867_SR_hcp_OAB_brch_GLBL_r06v01.indd 4 12/17/18 4:30 PM