The StimRouter neuromodulation system is a minimally invasive implantable device for treating chronic peripheral nerve pain. A clinical study of 94 patients found that StimRouter treatment significantly reduced pain and improved quality of life compared to a control group, with no serious device-related adverse events. The StimRouter system consists of an implanted lead, external pulse transmitter worn on the skin, and patient programmer to control stimulation programs. It targets pain at its precise origin with a one-time outpatient procedure.

1. StimRouter Neuromodulation Therapy
For Chronic Peripheral Nerve Pain
LIVE YOUR LIFE!
CONTROL YOUR PAIN,
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2. TARGET PAIN AT ITS ORIGIN
The StimRouter™
Neuromodulation System is the only implantable neuromodulation device indicated
for pain management in adults with severe intractable chronic pain of peripheral nerve origin,
excluding the craniofacial region.
CLINICAL STUDY RESULTS: SAFETY & EFFICACY
Ninety four (n=94) subjects with chronic peripheral pain in the
upper extremity, lower extremity or trunk, were implanted with
the StimRouter Neuromodulation System for a 12-month study.
• 19 different peripheral nerves were stimulated
HOW DOES IT WORK?
Applications may include
chronic pain conditions located
at or relating to:
• Upper or lower limbs
• Entrapment syndromes
• Intercostal neuralgias
• Other peripheral injuries
or diseases
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 ms
• Amplitude: up to 30 mA
ADVANCED DESIGN DELIVERS SIMPLICITY
EPT and Electrode Patch:
The External Pulse Transmitter (EPT) delivers
Neuromuscular Electrical Field Stimulation (NMEFS)
through the electrode patch to the implanted lead.
• Attaches (snaps) onto the disposable gel electrode patch
• Externally worn, low-profile design
• Rechargeable; can last up to two days on one charge
The Lead:
The implantable lead delivers low-level electrical impulses
directly to the site of pain. It is the only component of the
StimRouter system that is implanted.
• Three stimulating electrodes and a receiver
• Flexible, thin, 15cm length for deep or shallow implants
• Integrated anchor designed to minimize lead migration
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 one-time, 20-30 minute, minimally invasive lead implant procedure.
• Targets pain at its precise origin, controlled by the patient.
• No implanted pulse generator. StimRouter pulse transmitter resides outside the body.
• Conditional MRI Safety to minimize restrictions on future diagnostic tests.
• Primary Efficacy Endpoint defined as a 30% decrease in pain
using the StimRouter without an increase in pain medicine.
• At 3-months, the group receiving StimRouter treatment
demonstrated a statistically significant improvement in pain
as compared to the control group (p<0.0001).
• StimRouter users showed significantly favorable outcomes
related to quality of life, pain reduction and satisfaction as
compared to those in the control group.
• No serious or unanticipated device related adverse events
occurred during active stimulation treatment, which yields
a 95% confidence interval of [0, 4.0%) for the SAE rate.
• Over 50% of the treatment group rated their satisfaction
at 8 or higher on a 10-point scale, with 0 indicating not satisfied
at all and 10 indicating completely satisfied.
Treatment vs. Control Group Responder Rates
at 3-months (p<0.0001)
60%
40%
20%
0%
Control Group Treatment Group
14% 14%
38%
40%
0%
33%
Lower Extremity Trunk Upper Extremity
Percent Pain Reduction in Secondary Efficacy Measures
(p<0.0001)
50%
30%
10%
0%
Control Group Treatment Group
Worst Pain Score Normal WorkWalking Ability Enjoyment of Life
5% 8%
30%
48% 36% 36%
6%
%PainReduction
3%
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3. StimRouter™
, Bioness and the Bioness Logo®
are trademarks of Bioness Inc. | www.bioness.com
Rx Only
© 2016 Bioness Inc.
Before using the StimRouter system, be certain to read the entire StimRouter Procedure Manual and Clinician Manual. Be certain to understand the
following safety information:
Indications for Use: The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain
of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial
region.
Contraindications: The Bioness StimRouter Neuromodulation System is contraindicated for:
Patients who have any active implanted device such as an implanted demand cardiac pacemaker or defibrillator, or any metallic implant in the immediate
area intended for implant. Maintain a minimum safe separation distance of 15 cm (6 in.) between the StimRouter Electrode with External Pulse
Transmitter and all other active implanted devices and metallic implants. Patients exposed to diathermy. Shortwave, microwave and/ or therapeutic
ultrasound diathermy should not be used on patients who have a StimRouter Neuromodulation System.
Warnings: Warnings: Magnetic resonance imaging (MRI), body-worn devices, security screening devices, electrosurgery devices, high-frequency surgical
equipment, pregnancy, long-term effectiveness of neurostimulation, programming, device components, flammable fuel or chemicals, driving and
operating machinery.
Precautions: Clinician training, medical devices/therapies, post-operative care, implant location, for single patient use only, postural changes, keep out
of reach of children, skin abnormalities, skin irritation, known or suspected heart problems, user patch placement and stimulation, expiration date, x-ray
examinations, implant failure, storage and handling.
Adverse Effects: Risks related to the implant procedure, risks related to stimulation, additional risks related to the system.
1. Poduri KR. Shoulder pain in stroke patients and its effect on rehabilitation. J Stroke Cerebrovascular Dis. 1993. 3:261-6
2. Van Ouwenaller, C, Laplace, P. M., & Chantraine A. (1986) Painful shoulder in hemiplegia. Archives of Physical Medicine and Rehabilitation, 67, 23–26.
3. See Bioness_StimRouter_Dcoument11_McRoberts Poster
Bioness Inc.
25103 Rye Canyon Loop | Valencia, CA 91355
800.211.9136 | 661.362.4850
info@bioness.com | www.bioness.com | www.stimrouter.com
Bioness Europe B.V.
Stationsweg 41 | 3331 LR Zwijndrecht, Nederland
Telefoon: +31.78.625.6088 | E-mail: international@nl.bioness.com
Bioness Neuromodulation Ltd.
8 Hanager St., POB 7304 | Hod Hasharon, Israel
+972.9.790.7100 | www.bioness.co.il
THE STIMROUTER ADVANTAGE
• Highly versatile implant to target multiple peripheral nerves
• Minimizes surgical and post-surgical complications
• Minimize recovery time and scarring
• Minimizes costs compared to more invasive treatments
• Targets precise area of pain, focal instead of global
• Custom pain management solution controlled by clinician and patient
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