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  4. > U.S. Neurostimulation Devices Market, Medtech Insight

An estimated 200 million people in the United States (U.S.) experience some degree of neurological impairment over the course of a lifetime. Among the many neurological disorders are chronic pain (including migraine headache), epilepsy, hearing loss, incontinence, major depression, Parkinson’s disease, sleep apnea, and visual impairment/blindness. Typically, the initial treatment option for these conditions is standard pharmacotherapy or surgery; however, neurostimulation is gaining in popularity as a viable alternative among many people in the U.S. and worldwide. The estimated number of neurostimulation implant procedures has more than doubled over the past decade, reaching more than 1 million worldwide.

Implantable neurostimulation systems typically consist of three implantable components (the extension, lead, and 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).

For the purposes of this report, the total U.S. market for implantable neurostimulation devices includes sales derived from systems for 8 therapy segments, including the 5 core, established areas of deep brain stimulation (DBS), gastric nerve stimulation (GNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS), as well as neural prostheses (cochlear and recently launched retinal implants) and newly FDA-approved Vagal Blocking (VBLOC) therapy, for the treatment of obesity.

The large and burgeoning market for implantable neurostimulation devices in the U.S. has reached nearly $2.3 billion in 2014. Despite the 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 startups and leading medical device companies. The market is expected to experience high single-digit growth over the next half-decade, with many industry experts expecting its value to rival the multibillion-dollar markets for implantable defibrillators and coronary stents. A major reason for such optimism is not only the products’ clinical and commercial success thus far, but also the need for more effective treatments for the large population of patients who suffer from debilitating, chronic, incurable conditions that require the long-term management of symptoms.

This dynamic, new report from Medtech Insight includes analyses of dozens of selected products, current/forecast markets (from 2014-2019), disease prevalence, competitors, market share by supplier, and opportunities in the U.S. Neurostimulation Devices Market. Specifically, this report covers leading and emerging implantable neurostimulation devices and next-generation technologies, as well as increasingly competitive less invasive or nonsurgical therapies, such as transcutaneous electrical nerve stimulation (TENS), peripheral nerve stimulation (PNS), transcutaneous magnetic stimulation (TMS), and external trigeminal nerve stimulation (eTNS).

Table Of Contents

U.S. Neurostimulation Devices Market, Medtech Insight

i Implantable Neurostimulation Devices Market
ii Methodology

Exhibit ES-1: Estimated US Prevalence of Selected Neurological Conditions
Exhibit ES-2: 2014, Implantable Neurostimulation Devices Market, Estimated Percentage of Sales, by Type of Therapy
Exhibit ES-3: 2015, Leading Competitors and Products in the Implantable Neurostimulation Devices Market

11 Implantable Neurostimulators
111 Deep Brain Stimulators
112 Gastric Nerve Stimulators
113 Sacral Nerve Stimulators
114 Spinal Cord Stimulators
115 Vagus Nerve Stimulators
116 Vagal Blocking for Obesity
117 Cochlear Implants
118 Retinal Implants
12 Noninvasive Peripheral Nerve Stimulation
13 Transcutaneous Electrical Nerve Stimulation
14 Closed-Loop Stimulation
15 Hypoglossal Nerve Stimulation
16 Transcutaneous Magnetic Stimulation
17 External Trigeminal Nerve Stimulation

Exhibit 1-1: Estimated US Prevalence of Selected Neurological Conditions
Exhibit 1-2: Selected Advantages and Disadvantages of Neurostimulation Therapy
Exhibit 1-3: Estimated Number of Neurostimulation Implants, by Selected Neurological Condition
Exhibit 1-4: Schematic Illustration of Deep Brain Stimulation

211 Alzheimer's Disease
2111 Beijing Pins Medical Co,
2112 The Magstim Company
2113 Functional
Neuromodulation Ltd
212 Attention-Deficit/Hyperactivity
2121 Brainsway
2122 NeuroSigma
213 Autism
2131 Brainsway
2132 MagVenture A/S
214 Blindness
2141 Bionic Vision Australia
2142 Pixium Vision
2143 Retina Implant AG

2144 Second Sight Medical
215 Chronic Depression
2151 Brainsway Ltd
2152 Cyberonics/Sorin Group
2153 Fisher Wallace
2154 MagVenture A/S
2155 Medtronic
2156 Neuronetics
2157 NeuroSigma
2158 St Jude Medical
2159 Others
216 Chronic Heart Failure
2161 BioControl Medical
2162 Cyberonics/Sorin Group
2163 Medtronic
2164 St Jude Medical
217 Chronic Migraine Headache
2171 Boston Scientific
2172 Medtronic
2173 St Jude Medical
2174 Others (Cluster Headache/Migraine)
21741 Autonomic Technologies, Inc
21742 ElectroCore, LLC
218 Chronic Pain
2181 Boston Scientific
2182 Medtronic
2183 St Jude Medical
21831 Spinal Modulation/St Jude Medical
21832 Neurotherm/
St Jude Medical
2184 Others
21841 Bioness, Inc
21842 Mainstay Medical
21843 NeuroMetrix
21844 Neuros Medical
21845 Nevro Corp
21846 Saluda Medical
21847 SPR Therapeutics
21848 Stimwave Technologies, Inc
219 Dystonia, Essential Tremor, and Parkinson's Disease
2191 Boston Scientific
2192 Medtronic
2193 St Jude Medical
2110 Epilepsy
21101 Beijing Pins Medical Co, Ltd
21102 Cerbomed GmbH
21103 CerebralRx/BioControl Medical
21104 Cyberonics/Sorin Group
21105 Electrical Geodesics, Inc
21106 Medtronic plc
21107 NeuroPace
21108 NeuroSigma
21109 NeuroVista/Cyberonics
2111 Foot Drop
21111 Bioness, Inc
2112 Gastro-Esophageal Reflux Disease
21121 EndoStim

2113 Gastroparesis
21131 Medtronic
2114 Hearing Loss
21141 Advanced Bionics AG/
Sonova Group
21142 Cochlear, Ltd
21143 MED-EL
2115 Incontinence
21151 Medtronic
21152 Advanced Uro-Solutions/
21153 Bioness, Inc
21154 Cogentix Medical
2116 Obesity
21161 EnteroMedics
21162 MetaCure
2117 Obsessive-Compulsive Disorder
21171 Medtronic
2118 Sleep Apnea
21181 ImThera Medical
21182 Inspire Medical Systems
21183 Respicardia
21184 Others
2119 Spinal Cord Injury/Paralysis
21191 BrainGate Research Team
21192 Synapse Biomedical
2120 Stroke
21201 MicroTransponder
2121 Tinnitus
21211 Brainsway
21212 Medtronic
21213 MicroTransponder

Exhibit 2-1: Functional Neuromodulation's DBS-f Technology and Early Clinical Results
Exhibit 2-2: NeuroSigma's Monarch eTNS system
Exhibit 2-3: MagVenture's MagPro100x System Utilized in Repetitive Transcranial Magnetic Stimulation
Exhibit 2-4: Bionic Vision Australia's Retinal Stimulation Technology
Exhibit 2-5: Pixium Vision's Bio-Mimetic Camera
Exhibit 2-6: Retina Implant's Subretinal Implant Technology
Exhibit 2-7: Second Sight Medical Product's Argus II Retinal Prosthesis System
Exhibit 2-8: The Fisher Wallace Stimulator
Exhibit 2-9: MagVenture's MagVita TMS Therapy system for the Treatment of Depression
Exhibit 2-10: Neuronetic's NeuroStar TMS Therapy System for the Treatment of Depression
Exhibit 2-11: BioControl Medical's CardioFit Stimulator
Exhibit 2-12: Autonomic Technologies' ATI Neurostimulation System
Exhibit 2-13: ElectroCore's Self-Administered gammaCore nVNS System for Treatment of Chronic Cluster Headache and Migraine
Exhibit 2-14: Boston Scientific's Precision Spectra SCS System
Exhibit 2-15: Medtronic's RestoreSensor with SureScan MRI Technology for the Treatment of Chronic Pain
Exhibit 2-16: St Jude Medical's New Prodigy System with Burst Technology for Improved Pain Management
Exhibit 2-17: St Jude Medical's Eon Neurostimulators for the Treatment of Chronic Pain
Exhibit 2-18: St Jude Medical's Constant Current Circuitry Technology
Exhibit 2-19: Clinical Results: a 50% Reduction in Back and Leg Pain after 2 Years in Patients Receiving St Jude Medical's Rechargeable Eon Neurostimulator
Exhibit 2-20: Neurotherm's Radiofrequency Ablation Technology Application to the Facet Joint in the Spine
Exhibit 2-21: NeuroMetrix's SENSUS Pain Management System for the Treatment of Chronic Intractable Pain
Exhibit 2-22: Neuros Medical's Altius System High Frequency Nerve Block Technology for the Treatment of Chronic, Peripheral Pain
Exhibit 2-23: Nevro's Senza SCS System
Exhibit 2-24: SPR Therapeutic's Smartpatch PNS System for the Treatment of Chronic Shoulder Pain
Exhibit 2-25: Stimwave Technologies' FREEDOM SCS System Wireless Pain Relief Technology
Exhibit 2-26: Medtronic's Activa Neurostimulator for the Treatment of Parkinson's Disease and Essential Tremor
Exhibit 2-27: Cerbomed's Noninvasive NEMOS t-VNS Device for Treatment of Refractory Epilepsy
Exhibit 2-28: Cyberonic's/Sorin Group's VNS Therapy System for the Treatment of Epilepsy
Exhibit 2-29: NeuroPace's RNS/Responsive Neurostimulation for the Suppression of Epileptic Seizures
Exhibit 2-30: NeuroVista/Cyberonic's Seizure Advisory System for the Prediction of Epileptic Seizures
Exhibit 2-31: Bioness' L300 Foot Drop FES System
Exhibit 2-32: The Enterra II Gastric Neurostimulator for the Treatment of Gastroparesis
Exhibit 2-33: Advanced Bionic's HiRes 90K Implant System for the Treatment of Hearing Loss
Exhibit 2-34: Cochlear Ltd's Nucleus 6 Sound Processor and Function of Cochlear Implant System
Exhibit 2-35: MED-EL's MAESTRO and SYNCHRONY Cochlear Implant Systems
Exhibit 2-36: Medtronic's InterStim Therapy System for the Treatment of Incontinence
Exhibit 2-37: Cogentix Medical's Urgent PC System for the Treatment of Overactive Bladder
Exhibit 2-38: EnteroMedics' Maestro System
Exhibit 2-39: Overview of EnteroMedics' VBLOC Therapy and Vagus Nerve Function
Exhibit 2-40: Potential Benefits and Risks of VBLOC Therapy
Exhibit 2-41: Comparison of VBLOC Therapy, Laparoscopic Banding, and Gastric Bypass
Exhibit 2-42: MetaCure's DIAMOND (TANTALUS) Gastric Stimulation System
Exhibit 2-43: The aura6000 System for the Treatment of Obstructive Sleep Apnea
Exhibit 2-44: Inspire Medical System's Inspire II System for the Treatment of Obstructive Sleep Apnea
Exhibit 2-45: An Illustration of Normal and Abnormal Breathing Patterns in Patients with Central Sleep Apnea
Exhibit 2-46: Synapse Biomedical's NeuRx Diaphragm Pacing System
Exhibit 2-47: MicroTransponder's Serenity System for the Treatment of Tinnitus

31 Market Forecast
32 Competitive Analysis
321 Market Share
3211 Medtronic plc
3212 Boston Scientific
3213 St Jude Medical
3214 Cyberonics/Sorin Group
33 Emerging Neurostimulation Technologies
331 Nevro Corp
332 Stimwave
333 Peripheral Nerve Stimulation
3331 Bioness
3332 Autonomic Technologies,

Exhibit 3-1: Selected Market Drivers and Limiters for Implantable Neurostimulation Devices
Exhibit 3-2: Implantable Neurostimulation Devices, Combined Market Forecast, 2014-2019
Exhibit 3-3: 2014, Implantable Neurostimulation Devices Market, Estimated Percentage of Sales, by Type of Therapy
Exhibit 3-4: US Neurostimulation Devices Market Forecast, by Therapy Segment, 2014-2019
Exhibit 3-5: 2015, Leading Competitors and Products in the Implantable Neurostimulation Devices Market
Exhibit 3-6: 2015-2019, Next-Generation Implantable Neurostimulation Systems Pending FDA Approval for Core Indications
Exhibit 3-7: 2014, Combined Implantable Neurostimulation Devices Market, Share by Supplier
Exhibit 3-8: 2014, Implantable Neurostimulation Devices Market (DBS/GNS/SCS/SNS/VNS Market, Excluding Cochlear and Retinal Implants), Share by Supplier
Exhibit 3-9: 2014, Implantable SCS Devices Market, Share by Supplier
Exhibit 3-10: 2014, Cochlear Implants Market, Share by Supplier
Exhibit 3-11: Selected Recently FDA-Approved (Implantable/External) Neurostimulation Devices, 2013-2015
Exhibit 3-12: Selected Implantable Neurostimulation Devices Expected to Launch in 2015-2016
Exhibit 3-13: Selected (Implantable/External) Neurostimulation Devices Expected to Launch in 2017-2019



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