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1、 Electrical and Magnetic Nerve Stimulation Markets Rures adquireret umbraculi, etiam tremulus matrimonii libere senesceret app February 2010 Kalorama Information A division of MarketR 38 East 29th Street Sixth Floor New York, New York 10016 212.807 .2660 t 800.298.5603 t 212.807 .2676 f ELECTRICAL
2、AND MAGNETIC NERVE STIMULATION APPLICATIONS, TECHNOLOGIES, AND MARKET POTENTIAL A KALORAMA INFORMATION MARKET BRIEFING Electrical and Magnetic Nerve Stimulation has been prepared by Kalorama Information. We serve business and industrial clients worldwide with a complete line of information services
3、and research publications. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-oriented executive by providing a thorough presentation of essential data and concise analysis. Mountaintop Medical February 2010 Copyright 2004 Kalorama Information Reproduction w
4、ithout prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY. 1 Electrostimulation and Neuroprosthetic Technology Introduction. 1 Scope of This Report. 3 A Strong Market Founda
5、tion 4 Future Directions 5 Market Size and Projections 6 Table 1-1: Electrical and Neurostimulation Equipment/Device Market by Application Method, 2006-2013 7 Figure 1-1: Electrical and Neurostimulation Equipment/Device Market by Application Method, 2006-2013. 8 CHAPTER TWO: INTRODUCTION TO ELECTROS
6、TIMULATION AND RELATED TECHNOLOGIES. 9 Stimulation Therapeutics for Muscles and Nerves 9 Table 2-1: Energy/Radiation Stimulation Medical Electronics Products 11 Medical Applications of External Electrode Modalities. 12 Electrical Stimulation. 12 Measurement and Diagnosis 13 Stimulation by Magnetic F
7、ield Pulses. 14 Ultrasonic and Short Wavelength Diathermy 14 Medical Applications of Implanted Electrode Modalities 15 Table 2-2: Implanted Electrode Stimulation Technologies 16 Bladder Stimulators 17 Carotid Sinus Nerve Stimulation. 17 Cochlear Implant 18 Deep Brain Stimulation 18 Electrical Contin
8、ence 19 Electrical Nerve Stimulation 20 Pelvic Floor Stimulation. 20 Phrenic Nerve Stimulation. 20 Sacral Nerve Stimulation . 21 Spinal Cord Stimulation. 21 Vagus Nerve Stimulation 22 iv Electrical often a third electrode, a reference electrode, is added to facilitate measurement and control. Wirele
9、ss 10 Electrical IR = infrared; ELF = Extremely Low Frequency (30-3000 Hz); VLF = Very Low Frequency (3-30 kHz); CT = computed tomography; MRI = magnetic resonance imaging; PRK = photorefractive keratectomy Source: U.S. FDA, Center for Devices and Radiological Health 12 Electrical involves implantat
10、ion of electrodes around a selected peripheral nerve. Stimulation is induced by a generator connected to antenna unit attached to skin surface. Epiretinal Prosthesis Array of microelectrodes on a chip, placed on surface of retina; electrodes stimulate the most superficial retinal nerve cells (gangli
11、on cells), which send signals to the optic nerve. Pelvic Floor Stimulation Electrical stimulator for exercising/strengthening pelvic floor musculature for treatment of stress and/or urge urinary incontinence Phrenic Nerve Stimulation Stimulator provides electrostimulation of phrenic nerve to contrac
12、t diaphragm rhythmically and produce breathing in patients who have hypoventilation Sacral Nerve Stimulation Stimulation for urinary incontinence, urgency-frequency syndrome, and urinary retention Spinal Cord Stimulation Implant device generates low-level electrical impulses that stimulate targeted
13、nerves along spinal cord; this stimulation interferes with transmission of pain signals to brain. Vagus Nerve Stimulation Stimulation for treatment of epilepsy and other seizures Source: Center for Medicare and Medicaid Services; Coverage Issues: Manual Durable Medical Equipment Chapter Two: Introdu
14、ction to Electrostimulation and Related Technologies 17 Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Bladder Stimulators Brief doses of electrical stimulation
15、can strengthen muscles in the lower pelvis in a way similar to exercising the muscles. Electrodes are temporarily placed in the vagina or rectum to stimulate nearby muscles. This can stabilize overactive muscles and stimulate contraction of urethral muscles. Electrical stimulation can be used to red
16、uce both stress incontinence and urge incontinence. Bladder stimulators are implanted in the body to locally stimulate a mass of electrically excitable tissue without stimulating nearby tissue structures. The apparatus includes a plurality of electrodes, each of the electrodes including a pair of co
17、nductors for carrying signals of positive and negative polarity, with each of the conductors having a plurality of electrically conductive coupling points for coupling to the mass of tissue. Bladder stimulators provide timed sequenced electrical impulses to the plurality of electrodes so that only o
18、ne of the electrodes has a voltage applied between its input terminals at any given time. An insulating backing placed between the electrodes and tissue structures surrounding the implanted stimulator for eliminating undesirable secondary tissue stimulation is used. Carotid Sinus Nerve Stimulation T
19、he carotid sinus nerve stimulation treatment for angina pectoris and supraventricular tachycardia is a useful tool in treating these conditions. The carotid sinus is a dilatation of the internal carotid artery near its origin by the common carotid artery. This area of the vessel is richly supplied b
20、y nerve receptors which lead into the carotid sinus nerve. Stimulation of the pressure receptors (baroreceptors) in the carotid sinuses and aortic arch results in reflex arteriolar dilation and reduction of heart rate and myocardial contractility. Ultimately, this leads to an inhibition of sympathet
21、ic output, along with a decrease in the release of rennin and antidiuretic hormone, which serves to reduce intravascular volume and tone. 18 Electrical people may be consuming inadequate nutrient amounts needed for maintenance of the skeletal system and to preserve the integrity of round, flat, and
22、tubular bones. Fractures are the major clinical consequence of osteoporosis. In 1990, there were 250,000 hip fractures in the U.S. and 1.7 million worldwide. Alarmingly, by the year 2040, this rate may soar to 840,000 hip fractures in the U.S. and 6.26 million worldwide. Monetary costs of bone fract
23、ures may grow inordinately given Americas aging population. Bone growth stimulation by electrostimulation is a FDA-approved method that enhances the process of healing. Most trauma and spinal surgeons have experience with these electrostimulation devices but are sometimes inclined to only prescribe
24、the products to a limited number of patients, even if the technology might be indicated for them. Chapter Three: External Electrical Stimulation Devices 47 Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whol
25、e or in any part, is strictly prohibited. EBI has received an expanded label claim from the FDA citing the mechanism of action for their pulsed electromagnetic field technology (EBI Bone Healing System) for osteobiologic stimulation. This new label claim truly differentiates EBIs bone growth technol
26、ogies from competitors. Only EBI has demonstrated, through extensive research, that its technologies increase the production of bone morphogenetic protein (BMP) and other growth factors necessary to facilitate the healing of fractures and fusions. BMP is a protein that stimulates bone growth in the
27、body and has been approved for use in spinal fusion surgery. The FDA recently approved BMP for use in spinal fusion surgeries. Spinal fusion surgery fuses one or more vertebrae to reduce pain and stabilize the spine. The traditional surgery takes a graft from the patients pelvic bone and transplants
28、 it to the spine to help fuse vertebrae together. The first bone growth technology product, the EBI Bone Healing System, received FDA approval in 1979 and became commercially available in 1980. More than 300,000 patients have been treated with EBI bone growth technologies. EBI is a subsidiary of Bio
29、met, Inc. A bone growth stimulator that uses PEMF technology is the Physio-Stim Lite from Orthofix. For CMF devices, Regentec offers the OL1000 Bone Growth Stimulator and Depuy Spine offers the SpinaLogic Bone Growth Stimulator. Exogen/Smith Medtronic and St. Jude Medicals deep brain stimulation tre
30、atments; and several other emerging developments by these companies and others such as Boston Scientific. Neuronetics is the leading provider of TMS systems and generates a bulk of the TMS sales with its NeuroStar TMS Therapy System, which received approval from the FDA in October 2008 for the indic
31、ation of Major Depressive Disorder. Overall, this is a highly dynamic yet uncertain market. The following table presents market forecasts for TMS, ECT and other miscellaneous technologies. Chapter Three: External Electrical Stimulation Devices 57 Copyright 2010 Kalorama Information Reproduction with
32、out prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Table 3-6 The World Market for Other External Electrostimulation Devices 2006-2013 Year Revenues (in millions) Percent Change 2006 $6 - 2007 6 5.0% 2008 7 12.7% 2009 8
33、 14.1% 2010 9 11.1% 2011 11 22.2% 2012 13 18.2% 2013 15 15.4% Compound Annual Growth Rate Period CAGR 2006-2009 10.5% 2009-2013 16.7% 2006-2013 14.0% Source: Kalorama Information 58 Electrical TENS/EMS; Ultrasound bone healing; and other equipment including ECT and TMS. In 2009, the combined market
34、value for these segments is estimated at $781 million. A steady overall compound annual growth rate (CAGR) of 3.5% results over the 2006 estimate of $704 million. Growth through 2013 is expected to remain steady with a market reaching $902 million and growth of 3.7%. 60 Electrical the IPG or receive
35、r is placed just under the skin in a practical location; and the leads are connected to the IPG or receiver. The electrodes on the leads stimulate the specific nerves that communicate between the spinal cord and the painful areas. The stimulation of these targeted nerves alters the brains perception
36、 of the pain signals. SCS is not considered an option until more conservative, less invasive, and/or less expensive pain therapies have failed. An important contributor to the success of SCS for pain management is a meticulous patient selection process. Important factors include diagnosis, medical h
37、istory, type of pain, pain severity, and pain location. SCS is most effective for treating chronic neuropathic pain (pain that originates in the nerves or nervous system). SCS is cleared by the FDA for the treatment of a variety of chronic pain types, including pain in the arm(s), leg(s), and/or tru
38、nk. SCS has received approval for distribution internationally through various governmental authorities. SCS vs TENS in Pain Relief Both TENS and SCS use electrical impulses, but they are different in how they work and in the types of pain that they can treat. A TENS unit is an external device. It d
39、elivers electrical impulses through pads placed directly on the skin over the painful site. TENS stimulation is weaker and localized to surface tissues. SCS has 74 Electrical the company has experienced annual sales increases of 20-25% in the spinal cord stimulation market over the past several year
40、s. Throughout the forecast period the spinal cord stimulation market is expected to increase by 8.4%, growing to a market valued at $2.2 billion. Growth will be fueled by the continued geographical and product line expansions by leading manufacturers and a steady demand for pain relief technologies.
41、 76 Electrical cardiac rhythm management; deep brain stimulation (DBS); sacral nerve stimulation (SNS); spinal cord stimulation (SCS); and vagus nerve stimulation (VNS). In 2009, the combined market value for these segments is estimated at $13.6 billion. A steady overall compound annual growth rate
42、(CAGR) of 5.4% results over the 2006 estimate of $11.6 billion. Growth through 2013 is expected to remain steady with a market reaching $16.5 billion. Chapter Four: Implanted Electrical and Neurological Stimulation Devices 97 Copyright 2010 Kalorama Information Reproduction without prior written per
43、mission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Table 4-8 Implantable Electrical and Neurological Stimulation Market by Product Segment 2006-2013 Revenues (in millions) Year Implantable Bone Growth Cardiac Rhythm Management Deep Brain (
44、DBS) Gastric Electrical (GES) Sacral Nerve (SNS) Spinal Cord (SCS) Vagus Nerve (VNS) Total Percent Change 2006 $11 $9,345 $432 $211 $171 $1,193 $230 $11,593 - 2007 13 9,803 459 227 182 1,317 220 12,221 5.4% 2008 15 10,305 485 242 192 1,445 240 12,924 5.8% 2009 16 10,750 528 256 203 1,578 244 13,575
45、5.0% 2010 17 11,283 561 270 214 1,718 249 14,312 5.4% 2011 17 11,740 597 284 227 1,859 255 14,979 4.7% 2012 18 12,209 651 298 239 2,010 261 15,686 4.7% 2013 18 12,780 700 311 253 2,179 270 16,511 5.3% Compound Annual Growth Rate Period Implantable Bone Growth Cardiac Rhythm Management Deep Brain (DB
46、S) Gastric Electrical (GES) Sacral Nerve (SNS) Spinal Cord (SCS) Vagus Nerve (VNS) Total 2006- 2009 12.2% 4.8% 6.9% 6.7% 5.9% 9.8% 2.0% 5.4% 2009- 2013 3.3% 4.4% 7.3% 5.0% 5.7% 8.4% 2.6% 5.0% 2006- 2013 7.0% 4.6% 7.1% 5.7% 5.8% 9.0% 2.3% 5.2% Source: Kalorama Information 98 Electrical Extension of l
47、ife expectancy; Improvement in heart function; and Reduction in the number of hospitalizations and emergency room visits due to heart failure A Phase III trial commenced October 2009. NEW DEVELOPMENTS AND ALTERNATIVE TECHNOLOGIES Magnetic Stimulation Alternative medical therapists say magnetic field
48、s influence the bodys natural electrical currents, improving blood circulation, boosting energy, and helping the bodys natural healing processes. According to this view, since nerves work by transporting electricity, and magnets affected electrical activities, then magnetic fields could influence ne
49、urological processes. Modern analytical and imaging instrumentation such as functional magnetic resonance imaging (fMRI) has documented extensive changes in the brain caused by magnetic forces. Also, double- blind studies have quantified changes in emotional states and memory following Chapter Five: Industry Trends and Issues 105 Copyright 2010 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly p