Access the full report here https://goo.gl/z3ZYyL The large and burgeoning global market for implantable neurostimulation devices is approaching nearly $4 billion worldwide. Despite lingering economic uncertainty and financial constraints that have affected many other medical device markets, this market is undergoing significant technological advancement due to heavy R&D and investment efforts by dozens of innovative startups and leading medical device companies. The market is expected to maintain high single-digit growth (under 10%) over the next half-decade, expanding by nearly $2 billion by 2020. A major reason for such optimism is not only the sustained and expanding clinical and commercial success of neurostimulation technologies, but also the ongoing, increasing need for safer and more effective treatments to effectively manage the debilitating, chronic symptoms of many incurable diseases/disorders that negatively affect the quality of life in millions of people worldwide. Implantable neurostimulation (also commonly termed “neuromodulation”) systems, the focus of this report, typically consist of three implantable components (the extension, lead, and battery/power source) and two external components (the control magnet and a handheld programmer). The extension is used to connect the lead to the power source, and the lead is used to deliver the electrical stimulation to the targeted nerve(s). Neurostimulators may be temporary or permanent, depending on their indication, and are limited by their battery life. Long-life batteries are either self-contained or attached percutaneously on the outside of the body. Some batteries are rechargeable, while others must be replaced periodically. Neurostimulation implant procedures are minimally invasive, reversible, and have demonstrated substantial success in carefully selected patient populations. Neurostimulation systems have gained credibility in treating intractable chronic pain and other debilitating diseases/disorders, such as drug-refractory epilepsy and Parkinson’s disease, and are expected to achieve even greater acceptance over the next decade due to their ability to provide significant relief to no-option patients who have failed standard medication or more conservative treatment. This dynamic, new report from Meddevicetracker profiles literally dozens of neurostimulation/neuromodulation devices and emerging technologies covering more than 20 treatment areas. A comprehensive market analysis is provided, including 5-year market forecasts (from 2015-2020) by region (US vs. ROW) and by 6 core therapy segments (deep brain stimulation (DBS), gastric nerve stimulation (GNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), vagus nerve stimulation (VNS) and cochlear implants. Access the full report here https://goo.gl/z3ZYyL

1. Medical Market and Technology Reports
GLOBAL NEUROSTIMULATION DEVICES MARKET
June 2016
www.meddevicetracker.com
SAMPLE PAGES

2. Global Neurostimulation Devices Market Executive Summary
EXECUTIVE SUMMARY
Billions of people worldwide experience some degree of neurological impairment
over the course of a lifetime. Although many people remain asymptomatic or are
able to tolerate the minor symptoms that may occur, many others seek treatment for
debilitating symptoms that affect daily functioning and quality of life. Typically, the
initial treatment option for many neurological disorders is standard medical (drug)
therapy or surgery; however, neurostimulation is gaining in popularity as a viable
alternative among many people in the U.S. and worldwide.
Implantable neurostimulation systems available in the U.S. market may be
temporary or permanent (depending on its indication) and typically consist of three
implantable and two external components, with the implantable extension
connecting the lead to the power source, and the lead used to deliver electrical
stimulation to targeted nerve(s).
Implant procedures are minimally invasive, reversible, and have demonstrated
substantial success in carefully selected patient populations. Neurostimulation
systems are expected to achieve greater acceptance over the next decade as they
are demonstrated to provide relief to no-option patients who are refractory to drug
or other conservative treatment. Among the major risks associated with
neurostimulation implants are the possibility of device-related erosion, infection,
or migration as well as sudden interruptions in therapy due to electrical or
mechanical problems, and abnormal stimulation due to a damaged device;
concomitant muscle stimulation, hematoma, implant site inflammation/pain, seizures,
and electromagnetic interference also may occur. Despite these risks, however,
neurostimulation may offer the only viable choice for selected patients with
debilitating conditions, and often results in fewer side effects compared with the use
of drug therapy.
Exhibit ES-1 presents the estimated prevalence of selected neurological conditions
in the U.S. and worldwide.
2016 Meddevicetracker ES-1 #MDT16003

3. Global Neurostimulation Devices Market Executive Summary
Exhibit ES-4: 2016, Leading Competitors and Products in the Global
Implantable Neurostimulation Devices Market
Condition(s) Neurostimulation
Therapy
Leading
Competitor
Lead
Product(s)
Blindness Retinal nerve
stimulation
Second Sight Medical
Products
Argus II
Chronic Pain SCS Medtronic RestoreSensor
SureScan MRI
with AdaptiveStim
Technology
Dystonia, Essential
Tremor, Parkinson’s
Disease
DBS Medtronic Activa DBS
therapy system
Epilepsy VNS Cyberonics VNS (Aspire)
Therapy System
Gastroparesis GNS Medtronic Enterra II System
Hearing Loss Cochlear implant Cochlear Ltd. Nucleus
Incontinence SNS Medtronic InterStim II
Obesity vBloc therapy EnteroMedics Maestro
Notes: vBloc = Vagal Blocking Therapy. Chronic pain includes intractable pain of the trunk
and/or extremities, and does not include acute episodes of pain such as that
involved in migraine headache. Incontinence includes both fecal and urinary
conditions. Medtronic’s deep brain stimulation therapy for dystonia and gastric nerve
stimulation has been approved under the Food and Drug Administration’s
Humanitarian Use Device designation.
Source: Medtech Insight
2016 Meddevicetracker ES-9 #MDT16003

4. Neurostimulation Technologies Overview Chapter 1
Major risks associated with neurostimulation implant procedures include the
possibility of device-related erosion, infection, or migration as well as sudden
interruptions in therapy due to electrical or mechanical problems, and abnormal
stimulation due to a damaged device or undesirable changes in stimulation. Other
risks may include concomitant muscle stimulation, gastrointestinal complications,
hematoma, implant site inflammation/irritation/pain, seizures, and seroma;
electromagnetic interference (such as that from therapeutic defibrillation, diathermy,
magnetic resonance imaging [MRI], radiofrequency ablation, and ultrasound) also
may occur. To address the latter issue, most medical device manufacturers have
developed next-generation neurostimulation systems that are MRI-compatible.
Overall, despite risks, neurostimulation may offer the only viable choice for selected
patients with severe, debilitating conditions, and results in fewer side effects
compared with the use of pharmacotherapy, which has become a significant
problem in one of the major treatment areas of chronic pain due to its highly
addictive nature.
Exhibit 1-1 presents the estimated prevalence of selected neurological conditions.
Exhibit 1-2 presents the advantages and disadvantages of neurostimulation therapy.
1.1 Implantable Neurostimulators
Leading implantable neurostimulation devices available include deep brain
stimulators (for the treatment of depression and movement disorders, such as
essential tremor, dystonia, and Parkinson’s disease); gastric nerve stimulators (for
gastroparesis); sacral nerve stimulators (for incontinence); spinal cord stimulators
(for chronic pain); vagus nerve stimulators (for epilepsy); neural prostheses
(cochlear implants, for hearing loss and emerging retinal implants for blindness); and
vagal blocking therapy (for obesity). The U.S. market for these types of products is
poised for significant growth during the forecast period covered by this report due to
the aging of the population and growth in age-related neurological
diseases/disorders as well as the need for effective, alternative non-drug therapies.
The estimated number of neurostimulation implant procedures has more than
doubled over the past decade, reaching more than 1.1 million worldwide. Exhibit 1-3
presents the worldwide population of patients who have received neurostimulation
implants, by selected neurological condition.
2016 Meddevicetracker 1-2 #MDT16003

5. Neurostimulation Devices and Competitors Chapter 2
2. NEUROSTIMULATION DEVICES AND COMPETITORS
Implantable electrical stimulators, also known as implantable pulse generators
(IPGs), neuromodulators, or neurostimulators (termed “neurostimulation devices” in
this report), have become more widely utilized as a treatment modality for many
debilitating neurological disorders, or a wide variety of conditions that afflict the
brain, spine, and the nerves that connect them, including but not limited to: chronic
pain, dystonia/essential tremor/Parkinson’s disease, epilepsy, gastroparesis, chronic
migraine, major depression, and urinary incontinence. Among the more established
and proven applications for neurostimulation devices are 5 core therapy areas:
deep brain stimulation (DBS, for movement disorders such as Parkinson’s disease);
vagus nerve stimulation (VNS, for epilepsy); gastric electrical stimulation (GES, for
gastroparesis); sacral nerve stimulation (SNS, for incontinence); spinal cord
stimulation (SCS, for chronic pain); and neural prostheses for hearing loss.
Over the past decade, there has been a major surge in growth from the development
of next-generation implantable neurostimulation technologies, as well as rising
competition from less invasive, nonsurgical, or “externally applied” stimulation
devices, including the office-based treatment of depression, chronic migraine,
epilepsy and overactive bladder (OAB). Dozens of companies have entered this
ever-growing, dynamic market, and are clinically investigating the safety and efficacy
of novel stimulation technologies for numerous chronic, debilitating, and drug-
refractory conditions, including (but not limited to):
• Alzheimer’s disease;
• attention-deficit hyperactivity disorder (ADHD);
• autism;
• blindness;
• chronic heart failure;
• chronic migraine;
• foot drop;
• gastro-esophageal reflux disease (GERD);
• obesity;
2016 Meddevicetracker 2-1 #MDT16003

6. Neurostimulation Devices and Competitors Chapter 2
Two-year results of the ReCharge study, reported in November, 2015, revealed
ongoing efficacy, reporting average weight loss 21% ± 25% EWL or 8% ±10% total
body weight loss (TBL). Fifty-eight percent of subjects experienced at least 5% TBL
and 45% had at least 7.5%TBL. Safety was also demonstrated, with only one
serious complication in the 2-year period. Additionally, metabolic parameter
improvements were sustained up to 24 months, and for those patients with either
pre-diabetes or metabolic syndrome at baseline, the 2-year data revealed a 50%
remission rate for pre-diabetes and 47% remission rate for metabolic syndrome. The
company also announced the double-blind period of the ReCharge Trial had been
completed, with the trial transitioning to a 5-year, open-label study of the safety and
effectiveness of vagal blocking. (EnteroMedics, November 2015)
Updated results of the ReCharge Study, published online April 5, 2016 in the journal
Obesity Surgery, revealed significant and sustained weight loss in the vBloc
population in the subsegment of “moderately obese” patients with an obesity-related
comorbid condition, compared to sham control. In the vBloc moderately obese
population, patients experienced 74% greater weight loss compared to a rigorous
sham control, resulting in an average loss of 33% of excess weight at 12 months.
Additionally, three quarters of patients lost at least 20% of their excess weight and a
quarter lost at least 50%. Authors concluded that vBloc therapy resulted in
significantly greater weight loss than the sham control among participants with
moderate obesity and comorbidities, and a well-tolerated safety profile.
(EnteroMedics, April 2016)
The safety and efficacy of EnteroMedic’s vBloc Neurometabolic Therapy technology
for treating obesity was reviewed by the American Society for Metabolic and
Bariatric Surgery (ASMBS), which issued a positive position statement in January
2016. The position statement, published by Pavlos Papasavas, MD, Maher El
Chaar, MD and Shanu N. Kothari, MD, on behalf of the ASMBS, in the journal
Surgery for Obesity and Related Diseases, was based on a review of the
mechanism of action and clinical results. The article stated that “the quantity of the
data available at this time (6 published studies, approximately 600 implanted
devices) and the length of follow-up indicate adequate safety and efficacy in the
short and medium term." Overall, the article concluded, "the society currently
supports...vBloc for the treatment of obesity and encourages members to participate
in post-FDA approval studies," and that "the prospective collection of vBloc
outcomes as part of the national bariatric accreditation program (MBSAQIP) is
2016 Meddevicetracker 2-192 #MDT16003

7. Global Implantable Neurostimulation Devices Market Chapter 3
Exhibit 3-2: Selected Market Drivers and Limiters for Implantable
Neurostimulation Devices
Drivers Limiters
Aging population and a corresponding increase
in neurological disorders, and continued strong
demand for safe and effective non-drug
therapies for chronic, drug-refractive,
intractable/debilitating conditions
Intense and growing competition from several
improved, next-generation implantable
systems impacting market share; increased
competition from noninvasive therapies (such
as peripheral nerve stimulation and TENS);
however, these technologies are limited as
they apply only to certain treatment areas
(such as chronic pain chronic depression and
epilepsy)
Benefits over surgery and drug treatment and
long-term cost-effectiveness
High initial cost of therapy
Excellent/growing body of clinical data for
certain segments of the market, with greater
clinical acceptance and awareness, particularly
for pain management
Physician and patient preference for drug
therapy and its ease of use; Greater marketing
is required to ease reluctance and increase
product knowledge
High profit margins with limited competition in
most market segments
Device battery and technological limitations
(however, this is improving due to the
introduction of next-generation products)
Reimbursement for approved therapies for
refractory cases
Reimbursement limitations for non-refractory
cases and reimbursement challenges in some
therapy areas (e.g., recent reductions in SCS
trialing reimbursement)
While several products serve small patient
populations, many others target moderate to
significantly large markets (e.g., sleep apnea,
obesity), with rapid expansion into new
treatment areas; market penetration is low,
leaving much room for sales growth in most
therapy areas
Many devices remain confined to humanitarian
use (thus being limited to treatment
populations of ≤4,000)
Development of innovative products, with the
launch or increased adoption of dozens of next-
generation products over the next decade
Continued weak economy limiting investment
in research and development and creating high
barriers to entry for smaller companies, in
particular
Note: TENS = transcutaneous electrical nerve stimulation.
Source: Meddevicetracker
2016 Meddevicetracker 3-6 #MDT16003

8. Global Implantable Neurostimulation Devices Market Chapter 3
Exhibit 3-3: (Continued)
Notes: Cochlear’s global cochlear implant sales exclude sound processor upgrades of
approximately $162.1M; total cochlear implant sales including sound processors
amounted to $826.8M in FY2015. St. Jude Medical’s sales exclude estimated RF
ablation revenues and Medtronic’s sales exclude estimated SynchroMed
revenues. St. Jude Medical’s FY2015 global neuromodulaton sales (including RF
ablation devices) totaled $475M. Medtronic’s FY2015 global neuromodulaton
sales (including SynchroMed revenues) totaled $1.977 billion. LivaNova global
neuromodulation sales are unadjusted to LivaNova’s fiscal year (or correspond to
Cyberonic’s fiscal year); transitional global neuromodulation revenue (25 April
2015 to 31 December 2015) totaled approximately $214.8M. Estimated revenues
are derived from company financials, if available, and are based on fiscal year
(FY) neurostimulation segmented revenues and do not reflect calendar-year sales
for all competitors (e.g., Medtronic reports odd fiscal year).
Source: Meddevicetracker
2016 Meddevicetracker 3-9 #MDT16003

9. Company Listing Appendix: A
COMPANY LISTING
Abbott
www.abbott.com
Advanced Bionics Corporation/
Sonova Holdings
www.advancedbionics.com
Aleva Neurotherapeutics SA
www.aleva-neuro.com
Autonomic Technologies, Inc.
http://www.ati-spg.com/us/en/
BioControl Medical, Inc.
www.biocontrol-medical.com
Bioness, Inc.
www.bioness.com
Bionic Vision Australia
www.bionicvision.org/au
Boston Scientific Corporation
www.bostonscientific.com
BrainGate Research Team
http://braingate2.org/index.asp
Brainsway Ltd.
www.brainsway.com/us
Cerbomed GmbH
www.cerbomed.com
CerebralRX/BioControl Medical LTD
www.biocontrol-medical.com
Cochlear, LTD
www.cochlear.com
Cogentix Medical
www.cogentixmedical.com
Cyberonics, Inc./LivaNova PLC
www.livanova.cyberonics.com
Electrical Geodesics, Inc.
www.egi.com
ElectroCore, LLC
http://gammacore.com/en/healthcarepr
oviders/
EndoStim
www.endostim.com
EnteroMedics, Inc.
www.enteromedics.com
Fisher Wallace
www.fischerwallace.com
Functional Neuromodulation, Ltd.
www.fxneuromod.com
Greatbatch Medical
www.greatbatchmedical.com
ImThera Medical, Inc.
www.imtheramedical.com
Inspire Medical Systems, Inc.
www.inspiresleep.com
LivaNova PLC
www.livanova.com
The Magstim Company LTD
www.magstim.com
MagVenture A/S
www.magventure.com
Mainstay Medical
www.mainstay-medical.com
2016 Meddevicetracker A-1 #MDT16003

10. Company Listing Appendix: A
MED-EL Corporation
www.medel.com
Medtronic plc
www.medtronic.com
MetaCure LTD
www.metacure.com
MicroTransponder, Inc.
www.microtransponder.com
NeuroMetrix, Inc.
www.neurometrix.com
Neuronetics, Inc.
www.neuronetics.com
NeuroPace, Inc.
www.neuropace.com
Neuros Medical, Inc.
www.neurosmedical.com
NeuroSigma, Inc.
www.neurosigma.com
Nevro Corp.
www.nevro.com
Nuvectra Corporation
http://nuvectramedical.com
Pixium Vision
www.pixium-vision.com
Respicardia, Inc.
www.respicardia.com
Retina Implant AG
retina-implant-de/en
Saluda Medical
www.saludamedical.com
Second Sight Medical Products, Inc.
www.secondsight.com
SPR Therapeutics LLC
www.sprtherapeutics.com
St. Jude Medical, Inc.
www.sjm.com
Stimwave Technologies,
Incorporated
www.stimwave.com
Synapse Biomedical, Inc.
www.synapsebiomedical.com
2016 Meddevicetracker A-2 #MDT16003