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Global Markets for Emerging Medical Device Technologies

CHAPTER 1 Introduction
MEDICAL TECHNOLOGY
STUDY BACKGROUND
STUDY GOALS AND OBJECTIVES
INTENDED AUDIENCE
SCOPE OF THE REPORT
METHODOLOGY AND INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 SUMMARY
EXECUTIVE SUMMARY
CARDIOVASCULAR
ORTHOPEDIC
NEUROLOGY
DIABETES CARE
IN VITRO DIAGNOSTICS
GI AND ENDOSCOPY
OPHTHALMICS
WOUND CARE MANAGEMENT
DRUG DELIVERY
SUMMARY TABLE GLOBAL MARKET FOR EMERGING MEDICAL DEVICE TECHNOLOGIES, BY SEGMENT, THROUGH 2021 ($ MILLIONS)
SUMMARY FIGURE GLOBAL MARKET FOR EMERGING MEDICAL DEVICE TECHNOLOGIES, BY SEGMENT, 2015-2021 ($ MILLIONS)
CHAPTER 3 EMERGING DEVICE TECHNOLOGIES IN CARDIOVASCULAR
MARKET
CARDIOVASCULAR DEVICES
TARGET DISEASES AND ECONOMIC BURDEN
ANGINA PECTORIS
TABLE 1 GLOBAL PREVALENCE OF ANGINA PECTORIS AND STROKE (SURVIVORS), THROUGH 2030 (THOUSANDS)
STROKE
TABLE 2 GLOBAL INCIDENCE OF STROKE AND CONGESTIVE HEART FAILURE, THROUGH 2030 (THOUSANDS)
HYPERTENSION
FIGURE 1 HYPERTENSION EPIDEMIOLOGY, BY PATIENT GROUP, 2015 (% OF TOTAL PATIENTS)
MORTALITY RATES
TABLE 3 GLOBAL DEATHS, BY CARDIOVASCULAR DISEASE, THROUGH 2030 (THOUSANDS)
FIGURE 2 DISTRIBUTION OF GLOBAL DEATHS, BY CARDIOVASCULAR DISEASE, 2015 (% OF TOTAL DEATHS DUE TO CARDIOVASCULAR DISEASES)
EMERGING DEVICE TECHNOLOGIES FOR HEART FAILURE
HEART FAILURE DEVICES
Cardiac Resynchronization Therapy (CRT) Devices
Ventricular Assist Device (VAD)
Wireless Heart Failure Sensor (CardioMEMS)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 4 GLOBAL MARKET FOR EMERGING HEART FAILURE DEVICE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 3 GLOBAL MARKET SHARES FOR EMERGING HEART FAILURE DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 5 GLOBAL MARKET FOR EMERGING HEART FAILURE DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 4 GLOBAL MARKET SHARES OF EMERGING HEART FAILURE DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND R&D PIPELINE DEVICE TECHNOLOGIES
Recently FDA Approved Device Technologies
CardioMEMS HF System (P100045A)
CONTAK CD CRT-D System (P010012)
R&D Pipeline Device Technologies
Symphony Heart Pump (from Abiomed)
Impella Pediatric Pump (from Abiomed)
Abiocor II (from Abiomed)
Impella CP Next Generation Emergency Heart Pump (from Abiomed)
Revivent-TC Ventricular Enhancement System (from BioVentrix)
MiniVAD (from Calon Cardio-Technology)
CathVAD (from Calon Cardio-Technology)
Hotor (from Coras Medical)
Endotronix Care Management Solution (from Endotronix)
ClearView Measurement System (from EPIC Research & Diagnostics)
TABLE 6 R &D PIPELINE DEVICE TECHNOLOGIES FOR HEART FAILURE
MiFlow VAD (from HeartWare)
SYNERGY Pocket Circulatory Assist Device (from HeartWare)
HW005 Ventricular Assist System (from HeartWare)
New Mitroflow (from LivaNova)
Platinium (Brady & Tachy) (from LivaNova)
Paradym CRT-D Tri-V (from LivaNova)
Symplicity Renal Denervation System (from Medtronic)
Chronicle ICD (from Medtronic)
MediGuide Enabled CRT (from Medtronic)
Chronicle IHM (from Medtronic)
Hemodynamic Monitor (from Retia Medical)
HeartPOD (from St. Jude Medical)
Promote LAP System (from St. Jude Medical)
Apica VAD Surgical Implant System SIS (from St. Jude Medical)
Vixiar Device (from Vixiar Medical)
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
TABLE 7 RECENT KEY STRATEGIC DEALS IN HEART FAILURE DEVICES TECHNOLOGIES, 2013-2015
EMERGING DEVICE TECHNOLOGIES FOR ELECTROPHYSIOLOGY (EP)
ELECTROPHYSIOLOGY (EP)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 8 GLOBAL MARKET FOR ELECTROPHYSIOLOGY DEVICE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 5 GLOBAL MARKET SHARES OF ELECTROPHYSIOLOGY DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 9 GLOBAL MARKET FOR ELECTROPHYSIOLOGY DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 6 GLOBAL MARKET SHARES OF ELECTROPHYSIOLOGY DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
TABLE 10 GLOBAL MARKET FOR ELECTROPHYSIOLOGY, BY TYPE, 2015 ($ MILLIONS)
FIGURE 7 GLOBAL MARKET SHARES OF ELECTROPHYSIOLOGY, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND R&D PIPELINE PRODUCTS
Recently FDA Approved Device Technologies
WATCHMAN LAA Closure Technology (P130013) (from Boston Scientific)
R&D Pipeline Device Technologies
Atrial Fibrillation Technology (from Actuated Medical)
CoolLoop (from Afreeze)
Next Generation Integrated Platform (from Apama Medical)
AtriCure Bipolar System (from AtriCure)
IntellaNav XP and IntellaNav MiFi OL (from Boston Scientific)
Artisan Control AF Catheter (from Hansen Medical)
Lambre LAA Occluder (from Lifetech Scientific)
Voyager Irrigated RF Ablation Catheter and Sheath System (from MicroPort Scientific)
VeriSense Ablation and EnSite HD Grid Catheter Mapping System
(from St. Jude Medical)
TABLE 11 KEY R &D PIPELINE DEVICE TECHNOLOGIES IN ELECTROPHYSIOLOGY
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
TABLE 12 RECENT KEY STRATEGIC DEALS IN ELECTROPHYSIOLOGY
EMERGING DEVICE TECHNOLOGIES FOR INTERVENTIONAL CARDIOLOGY
INTERVENTIONAL CARDIOLOGY
Rapid Exchange PTCA Catheter
Intravascular Ultrasound Systems (IVUS)
Bioresorbable Vascular Scaffolds (BVS)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 13 GLOBAL MARKET FOR INTERVENTIONAL CARDIOLOGY DEVICE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 8 GLOBAL MARKET SHARES OF INTERVENTIONAL CARDIOLOGY DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 14 GLOBAL MARKET FOR INTERVENTIONAL CARDIOLOGY DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 9 GLOBAL MARKET SHARES OF INTERVENTIONAL CARDIOLOGY DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND R&D PIPELINE DEVICE TECHNOLOGIES
Recently FDA Approved Device Technologies
Absorb GT1 BVS System (P150023) (from Abbott)
R&D Pipeline Device Technologies
Stanza Bioresorbable (from 480 Biomedical)
Esprit Drug-Eluting BVS (from Abbott Laboratories)
Adient Medical Totally Absorbable Vascular Filter (from Adient
Medical)
APTITUDE (120-micron) Bioresorbable Drug-Eluting Coronary Scaffold
(from Amaranth Medical)
EmboMedics Resorbable Microspheres (from AngioDynamics)
BioBelle Bioabsorbable Cardiac Matrix (from Bellerophon
Therapeutics)
DREAMS 2nd Generation (from BIOTRONIK)
Fully Resorbable Drug-Eluting Scaffold System (from Boston Scientific)
CINATRA ISA 247 Coated Coronary Stent System (from Getinge)
MGuard Coronary Plus Bio-Absorbable Drug-Eluting Mesh (from InspireMD)
Firefalcon Bioresorbable (from MicroPort Scientific)
MicroPort Firesorb Bioresorbable Rapamycin Target Eluting Coronary
Scaffold (from MicroPort Scientific)
ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold (from
REVA Medical)
Fantom Bioresorbable Scaffold (from REVA Medical)
TABLE 15 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR BIORESORBABLE VASCULAR SCAFFOLD (BVS)
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
TABLE 16 RECENT KEY STRATEGIC DEALS FOR INTERVENTIONAL CARDIOLOGY, 2012-2015
EMERGING DEVICE TECHNOLOGIES FOR ENDOVASCULAR ANEURYSM/AORTIC REPAIR (EVAR)
AORTIC ANEURYSM (ABDOMINAL AND THORASIC)
ENDOVASCULAR REPAIR OF AORTIC ANEURYSMS
TABLE 17 EPIDEMIOLOGY OF AAA AND TAA
AAA AND TAA STENT GRAFTS
TABLE 18 GLOBAL NUMBER OF AORTIC ANEURYSM REPAIR PROCEDURES, BY PROCEDURE TYPE, 2015 (NO.)
SHIFT FROM OPEN TO EVAR
FIGURE 10 U.S. AAA PROCEDURES, BY SURGERY TYPE, 2015 (%)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 19 GLOBAL MARKET FOR EVAR AND TEVAR, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 11 GLOBAL MARKET SHARES OF EVAR AND TEVAR, BY REGION, 2015-2021 (%)
TABLE 20 GLOBAL MARKET OF EVAR AND TEVAR, BY ANEURYSM TYPE, 2015 ($ MILLIONS)
FIGURE 12 GLOBAL MARKET SHARES FOR EVAR AND TEVAR, BY ANEURYSM TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND R&D PIPELINE DEVICE TECHNOLOGIES
FDA Approved Device Technologies
Endologix PowerLink System (P040002) (from Endologix)
Zenith AAA Endovascular Graft and the H&L-B One-Shot Introduction System (P020018) (from Cook)
Endurant Stent Graft System (P100021) (from Medtronic)
Key R&D Pipeline Device Technologies
Ventana Fenestrated Stent Graft System (from Endologix)
Xpand (from Endologix)
AFX3 Endovascular AAA System (from Endologix)
VELA2 Proximal Endograft System (from Endologix)
Nellix w/Snorkels (from Endologix)
Paravisceral System (from Endologix)
Nellix ChEVAS (from Endologix)
Ovation Alto System (from Endologix)
NEXUS (from Endospan)
HORIZON AAA Repair (from Endospan)
Ankura Branched/Fenestrated Stent Graft (from Lifetech Scientific)
Thoracic Stent-Graft (from Lombard Medical Technologies)
IntelliFlex LP Delivery System (from Lombard Medical Technologies)
Valiant Mona LSA System (from Medtronic)
Endurant Evo AAA Stent Graft (from Medtronic)
Valiant Evo (from Medtronic)
TAAA Debranching Stent Graft Endovascular Stent (from Medtronic)
Valiant TAAA Stent Graft System (from Medtronic)
Ultra-Low Profile AAA Stent-Graft System (from MicroPort Scientific)
Thoraflex (from Terumo)
Tumbao EndoVascular Aortic Repair System (from Transcatheter Technologies)
GORE EXCLUDER Conformable AAA Endoprosthesis (from W. L. Gore)
TABLE 21 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR
ENDOVASCULAR AORTIC REPAIR
STRATEGIC DEAL: ENDOLOGIX ACQUIRED TRIVASCULAR TECHNOLOGIES
COMPETITION IN EVAR SEGMENT
EMERGING DEVICE TECHNOLOGIES FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)
CONVENTIONAL ICD
SUBCUTANEOUS ICD (S-ICD)
MARKET SIZE AND GROWTH ANALYSIS FOR SUBCUTANEOUS ICD
TABLE 22 GLOBAL MARKET FOR S-ICD, THROUGH 2021 ($ MILLIONS)
Market Growth Drivers and Restraints
KEY MARKETED AND PIPELINE DEVICE TECHNOLOGIES
TABLE 23 RECENTLY FDA APPROVED S-ICD DEVICE TECHNOLOGIES EMERGING DEVICE TECHNOLOGIES FOR PERIPHERAL VASCULAR DEVICES
PERIPHERAL VASCULAR DEVICES
Atherectomy
Synthetic Surgical Grafts
Drug-Coated Balloons (DCB)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 24 GLOBAL MARKET FOR PERIPHERAL VASCULAR DEVICE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 13 GLOBAL MARKET SHARES OF PERIPHERAL VASCULAR DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 25 GLOBAL MARKET FOR PERIPHERAL VASCULAR DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 14 GLOBAL MARKET SHARES OF PERIPHERAL VASCULAR DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND PIPELINE DEVICE TECHNOLOGIES
Recently FDA Approved Device Technologies
Misago Peripheral Stent System (P140002) (Terumo)
Protege GPS Self-Expanding Peripheral Stent System (P060001/S020)
(ev3)
Key R&D Pipeline Device Technologies
Callisyn Peripheral Microcatheter (from Callisyn Biomedical)
MGuard Peripheral Plus Bio-Stable Mesh (from InspireMD)
Next-Generation Drug-Coated Balloon with Kinesyx Technology (from Interface Biologics)
Reewarm PTX Drug Balloon Dilation Catheter (from MicroPort Scientific)
Reewarm18 Peripheral Balloon Dilation Catheter (from MicroPort Scientific)c
Drug-Coated Balloon (from Elixir Medical)
Thermal Sensing System (from Accumed Systems)
NG PROMUS Stent System (from Boston Scientific)
Diamondback 360 Coronary Micro Crown Orbital Atherectomy System
(from Cardiovascular Systems)
SESAME Stent (from Palmaz Scientific)
Innova Peripheral Vascular Drug-Eluting Stent (from Boston Scientific)
TABLE 26 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR PERIPHERAL VASCULAR MARKET
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
TABLE 27 RECENT KEY STRATEGIC DEALS FOR PERIPHERAL VASCULAR DEVICE TECHNOLOGIES, 2012-2015
EMERGING TECHNOLOGIES FOR TRANSCATHETER HEART VALVE
TECHNOLOGIES
TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)
TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 28 GLOBAL MARKET FOR TRANSCATHETER HEART VALVE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 15 GLOBAL MARKET SHARES OF TRANSCATHETER HEART VALVE TECHNOLOGIES, BY REGION, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND PIPELINE DEVICE TECHNOLOGIES
Recently FDA Approved Device Technologies
Melody Transcatheter Pulmonary Valve (P140017) (from Medtronic)
Medtronic CoreValve System (P130021/S010) (from Medtronic)
Edwards SAPIEN 3 Transcatheter Heart Valve (P140031) (from Edwards Lifesciences)
R&D Pipeline Device Technologies
Tendyne Transcatheter Mitral Valve Implant (from Abbott)
BIOVALVE Prosthesis (from BIOTRONIK)
HLT Transcatheter Valve System (from Bracco)
Mitra-Spacer (from Cardiosolutions)
Colibri Aortic Heart Valve (from Colibri Heart Valve)
Delta Aortic Heart Valve (from Colibri Heart Valve)
Mitramaze Valve Repair System (from Coramaze Technologies)
CENTERA Transcatheter Heart Valve and ZETA Surgical Valve (from
Edwards Lifesciences)
FORTIS Transcatheter Mitral Heart Valve (from Edwards Lifesciences)
CardiAQ's 2nd Generation Transcatheter Mitral Valve (from Edwards
Lifesciences)
SAPIEN 3 (from Edwards Lifesciences)
Beating Heart Mitral Valve Repair (from Harpoon Medical)
JenaValve System (Transfemoral) (from JenaValve Technology)
Embolic Deflection Device (from Keystone Heart)
Perceval S Sutureless Aortic Valve (from LivaNova)
Mitra-Spacer (from LivaNova)
HighLife Transcatheter Mitral Valve (from LivaNova)
Caisson Mitral Replacement System (from LivaNova)
Model 400 Aortic Valve Bioprosthesis (from Medtronic)
Twelve Transcatheter Mitral Valve Replacement System (from Medtronic)
Harmony Transcatheter Pulmonary Valve (from Medtronic)
CoreValve Evolut 34R System (from Medtronic)
enCorTC (from MiCardia)
MitrAssist (from MitrAssist)
Tiara (from Neovasc)
AngioScore Valvuloplasty Scoring Balloon (from Spectranetics)
TAVI Systems (from Symetis)
Trinity TAVI System (from Transcatheter Technologies)
Tresillo Mitral Valve Implantation System (from Transcatheter
Technologies)
TABLE 29 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR TRANSCATHETER HEART VALVE MARKET
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
TABLE 30 RECENT KEY STRATEGIC DEALS FOR TRANSCATHETER HEART VALVE MARKET, 2010-2016
COMPETITIVE LANDSCAPE IN EMERGING CARDIOVASCULAR DEVICE TECHNOLOGIES MARKET
TABLE 31 GLOBAL MARKET FOR EMERGING CARDIOVASCULAR DEVICE TECHNOLOGIES, BY LEADING COMPANIES, 2015 ($ MILLIONS)
FIGURE 16 GLOBAL MARKET SHARES OF LEADING COMPANIES IN EMERGING CARDIOVASCULAR DEVICE TECHNOLOGIES, 2016 (%)
OTHER CARDIOVASCULAR EMERGING DEVICES TECHNOLOGIES
WEARABLE CARDIOVERTER DEFIBRILLATOR
MINI HEART PUMP (IMPELLA RP SYSTEM (H140001) FROM ABIOMED)
SUTURELESS MYOCARDIAL PACING LEADS
TRANSCATHETER PACEMAKER SYSTEM
ALGISYL-LVR MINIMALLY INVASIVE (FROM LONESTAR HEART)
HOTOR (FROM CORAS MEDICAL)
TUBRIDGE PARENT ARTERY RECONSTRUCTION DEVICE (FROM MICROPORT SCIENTIFIC)
PENUMBRA LIBERTY STENT SYSTEM (FROM PENUMBRA)
CHAPTER 4 EMERGING DEVICE TECHNOLOGIES IN ORTHOPEDIC MARKET
ORTHOPEDIC MARKET
TARGET DISEASES AND INDICATIONS
EPIDEMIOLOGY OF MUSCULOSKELETAL DISORDERS
Osteoarthritis
Rheumatoid Arthritis
Osteoporosis
Gout (Gouty Arthritis)
Back and Neck Pain
TABLE 32 GLOBAL SYMPTOMATIC PREVALENCE OF KEY MUSCULOSKELETAL DISORDERS, BY TYPE, THROUGH 2021 (THOUSANDS)
FIGURE 17 DISTRIBUTION OF GLOBAL SYMPTOMATIC PREVALENCE OF KEY MUSCULOSKELETAL DISORDERS, BY REGION, 2015 (THOUSANDS)
MORTALITY RATES OF MUSCULOSKELETAL DISEASES
TABLE 33 GLOBAL DEATHS, BY MUSCULOSKELETAL DISORDER, THROUGH 2030 (NO.)
FIGURE 18 DISTRIBUTION OF GLOBAL DEATHS, BY MUSCULOSKELETAL DISORDER, 2015 (% OF TOTAL DEATHS DUE TO MUSCULOSKELETAL DISORDERS)
EMERGING ORTHOPEDIC DEVICE TECHNOLOGIES
EMERGING DEVICE TECHNOLOGIES FOR EXTREMITY JOINT RECONSTRUCTION
(EXCLUDING HIP AND KNEE)
SHOULDER RECONSTRUCTION AND REPLACEMENT
SMALL JOINTS RECONSTRUCTION AND REPLACEMENT
Foot and Ankle
Hand and Wrist
Elbow
Digits
MARKET SIZE AND GROWTH ANALYSIS
TABLE 34 GLOBAL EXTREMITY JOINT RECONSTRUCTION PROCEDURES, BY TYPE, THROUGH 2021 (NO.)
TABLE 35 GLOBAL MARKET FOR EXTREMITY JOINT RECONSTRUCTION DEVICE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 19 GLOBAL MARKET SHARES OF EXTREMITY JOINT RECONSTRUCTION DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 36 GLOBAL MARKET FOR EXTREMITY JOINT RECONSTRUCTION DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 20 GLOBAL MARKET SHARES OF EXTREMITY JOINT RECONSTRUCTION DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
TABLE 37 GLOBAL MARKET FOR SMALL JOINT RECONSTRUCTION DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 21 GLOBAL MARKET SHARES OF SMALL JOINT RECONSTRUCTION DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND PIPELINE PRODUCTS
Recently FDA Approved Device Technologies
Arthrex PIP Dart (from Arthrex)
Infinity Total Ankle System (from Wright Medical)
ToeTac Hammertoe Fixation System (from Restore Surgical)
Simpliciti Ultra Short Stem Total Shoulder Arthroplasty (from Wright Medical)
Aequalis Perform+ Shoulder System (from Tornier)
Fibulock Nail (from Sonoma Orthopedic Products Inc.)
Initial R Distal Radius Kit (from Newclip Technics)
Proxifuse Hammertoe Correction System (from Cartiva Inc.)
TABLE 38 RECENTLY APPROVED DEVICE TECHNOLOGIES FOR
EXTREMITY JOINT RECONSTRUCTION AND REPLACEMENT
R&D Pipeline Device Technologies
Arxis (from Audax Medical)
Advanced Shoulder Options (from Integra LifeSciences)
Akilos Total Ankle System (from Implants International)
2-Piece Total Ankle Replacement (from Integra LifeSciences)
Augment Injectable Bone Graft (from Wright Medical Group)
Augment Chronic Tendinopathy (from Wright Medical Group)
Invision Revision Ankle System (from Wright Medical)
Salvation External Fixation System (from Wright Medical)
InSpace Balloon System (Orthospace Ltd.)
Cartiva Synthetic Cartilage Implant (from Cartiva Inc.)
TABLE 39 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR
EXTREMITY JOINT RECONSTRUCTION
REIMBURSEMENT
EMERGING DEVICE TECHNOLOGIES FOR SOFT TISSUE FIXATION AND REPAIR MARKET SIZE AND GROWTH ANALYSIS
TABLE 40 GLOBAL MARKET FOR SOFT TISSUE FIXATION AND REPAIR DEVICE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 22 GLOBAL MARKET SHARES OF SOFT TISSUE FIXATION AND REPAIR DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 41 GLOBAL MARKET FOR SOFT TISSUE FIXATION AND REPAIR DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 23 GLOBAL MARKET SHARES OF SOFT TISSUE FIXATION AND REPAIR DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND R&D PIPELINE PRODUCTS
Recently FDA Approved Device Technologies
Univers Apex Subscapularis Repair Suture Kit (from Arthrex Inc.)
Q-Fix All-Suture Anchor (from Smith & Nephew)
SutureFIX Ultra Soft Anchor (from Smith & Nephew)
TABLE 42 RECENTLY APPROVED DEVICE TECHNOLOGIES FOR SOFT TISSUE FIXATION AND REPAIR
R&D Pipeline Device Technologies
A3T01 (from Aegeria Soft Tissue)
Scaffolds for Artificial Cartilage Development (from Bio-Scaffold
International)
F2A Peptide (from BioSurface Engineering Technologies)
REPAIR Bone Putty (from Carmell Therapeutics)
DiscCell (from Gentis)
L-C Ligament (from Soft Tissue Regeneration)
Tissue Regeneration Systems (from Tissue Regeneration Systems)
dCELL Meniscus (from Tissue Regenix Group)
Z-Lig Xenograft (Aperion Biologics Corp.)
TABLE 43 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR SOFT TISSUE FIXATION AND REPAIR
REIMBURSEMENT
OTHER EMERGING ORTHOPEDIC DEVICE TECHNOLOGIES
SUPERION INTERSPINOUS SPACER (P140004) (VERTIFLEX)
ACTIVL ARTIFICIAL DISC (P120024) (AESCULAP IMPLANT SYSTEMS)
RADIESSE INJECTABLE IMPLANT (P050052/S049) (MERZ NORTH AMERICA)
RESTYLANE LYFT WITH LIDOCAINE INJECTABLE GEL INJECTABLE DERMAL FILLER (P040024/S073) (GALDERMA LABORATORIES)
COMPETITIVE LANDSCAPE IN EMERGING ORTHOPEDIC DEVICE
TECHNOLOGIES MARKET
TABLE 44 LEADING COMPANIES IN THE GLOBAL MARKET FOR EMERGING ORTHOPEDIC DEVICE TECHNOLOGIES, 2015 ($ MILLIONS)
FIGURE 24 GLOBAL MARKET SHARES OF LEADING COMPANIES IN EMERGING CARDIOVASCULAR DEVICE TECHNOLOGIES, 2015 (%)
CHAPTER 5 EMERGING DEVICE TECHNOLOGIES IN NEUROLOGY MARKET
NEUROVASCULAR DEVICES
TABLE 45 TARGET DEVICE TECHNOLOGIES FOR KEY DISEASE INDICATIONS
EMERGING NEUROVASCULAR DEVICE TECHNOLOGIES
CEREBRAL THROMBECTOMY DEVICES
FLOW DIVERTER FOR ANEURYSM
CAROTID ARTERY STENTING (CAS) SYSTEM
MARKET SIZE AND GROWTH ANALYSIS
TABLE 46 GLOBAL MARKET FOR NEUROVASCULAR DEVICE TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 25 GLOBAL MARKET SHARES OF NEUROVASCULAR DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 47 GLOBAL MARKET FOR NEUROVASCULAR DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 26 GLOBAL MARKET SHARES OF NEUROVASCULAR DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
FIGURE 27 GLOBAL MARKET SHARES OF CEREBRAL ANEURYSM DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
KEY MARKETED AND PIPELINE PRODUCTS
Recently FDA Approved Device Technologies
Senza SCS System (P130022) (Nevro Corp.)
Pipeline Embolization Device and Pipeline Flex (from Medtronic)
ENROUTE Transcarotid Stent System
The Solitaire 2 Revascularization Device
Trevo Retriever (from Stryker)
TABLE 48 RECENTLY APPROVED DEVICE TECHNOLOGIES FOR NEUROVASCULAR MARKET
R&D Pipeline Device Technologies
Surpass NeuroEndoGraft Flow Diverter (from Stryker)
ENTERPRISE Vascular Reconstruction Device (from J&J)
TABLE 49 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR NEUROVASCULAR MARKET
CoilControl 3D (from CVTec Cerebrovascular Technologies)
Gaudi Vascular Zippered Catheter (from Gaudi Vascular)
Gaudi Vascular Customized Stents (from Gaudi Vascular)
Gaudi Vascular Branched Stents (from Gaudi Vascular)
NVGuard Neurovascular (from InspireMD)
Shape Memory Polymer - Cerebral Aneurysm (from Shape Memory Therapeutics)
tDCS Accessories (from Soterix Medical)
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
Bionik Laboratories acquired Interactive Motion Technologies
Stryker acquired Valenat/Synergetics USA's Neuro Portfolio
Medtronic acquired Medina
Integra Lifesciences acquired Covidien's Confluent Surgical Products
Covidien acquired Nfocus Neuromedical
Stryker acquired Surpass Medical
Stryker Acquired Concentric Medical
Covidien Acquired EV3
Stryker Acquired Neurovascular Product Line from Boston Scientific
Johnson & Johnson acquired Micrus Endovascular
TABLE 50 RECENT KEY STRATEGIC DEALS FOR NEUROVASCULAR MARKET, 2010-2016
COMPETITIVE LANDSCAPE IN THE NEUROVASCULAR MARKET
TABLE 51 GLOBAL MARKET FOR NEUROVASCULAR DEVICE TECHNOLOGIES, BY LEADING COMPANIES, 2015 ($ MILLIONS)
FIGURE 28 GLOBAL MARKET SHARES OF NEUROVASCULAR DEVICE TECHNOLOGIES, BY LEADING COMPANIES, 2015 (%)
NEUROMODULATION DEVICES
TABLE 52 NEUROMODULATION DEVICES AND TARGET DISEASE
INDICATIONS
EMERGING NEUROMODULATION DEVICE TECHNOLOGIES
CEREBRAL THROMBECTOMY DEVICES
FLOW DIVERTER FOR ANEURYSM
CAROTID ARTERY STENTING (CAS) SYSTEM
MARKET SIZE AND GROWTH ANALYSIS
TABLE 53 GLOBAL MARKET FOR NEUROMODULATION DEVICE TECHNOLOGIES, BY REGION, 2015-2021 ($ MILLIONS)
FIGURE 29 GLOBAL MARKET SHARES OF NEUROMODULATION DEVICE TECHNOLOGIES, BY REGION, 2015 (%)
TABLE 54 GLOBAL MARKET FOR NEUROMODULATION DEVICE TECHNOLOGIES, BY TYPE, 2015 ($ MILLIONS)
FIGURE 30 GLOBAL MARKET SHARES OF NEUROMODULATION DEVICE TECHNOLOGIES, BY TYPE, 2015 (%)
KEY MARKETED AND PIPELINE PRODUCTS
Recently FDA Approved Device Technologies
Brio Neurostimulation System (P140009) (from St. Jude Medical)
Algovita Spinal Cord Stimulation System (P130028) (from Nuvectra Corp.)
Nevro Senza SCS System (P130022) (from Nevro Corp.)
Medtronic Interstim Sacral Nerve Stimulation Therapy System
(P080025) (from Medtronic)
TABLE 55 KEY NEUROMODULATION PRODUCT BRANDS FROM LEADING PLAYERS
TABLE 56 RECENTLY APPROVED DEVICE TECHNOLOGIES FOR NEUROMODULATION MARKET
Medtronic's Enterra Neurostimulator
R&D Pipeline Device Technologies
StimRouter Neuromodulation System (from Bioness)
Bioness Battery Powered Microstimulator (from Bioness)
Vagal Nerve Stimulation (from Boston Scientific)
Multi-coil Transcranial Magnetic Stimulator (from Cervel Neurotech)
Life-Tech, Iontophor PM Deluxe Constant Current Stimulator (from Lifetech Scientific)
PrimeAdvanced Neurostimulator [Heart Failure] (from Medtronic)
SureStim-1 Implant (from Medtronic)
Serenity System (from MicroTransponder)
External Spinal Cord Neuromodulation System, Implantable Spinal
Cord Neuromodulation System (from NeuroRecovery Technologies)
SetPoint Vagus Nerve Stimulator (from SetPoint Medical)
MOBILE Neuromodulation (from Soterix Medical)
Low Field Magnetic Stimulation (LFMS) Device (from Tal Medical)
TABLE 57 KEY R &D PIPELINE DEVICE TECHNOLOGIES FOR
NEUROMODULATION MARKET
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
Theragen Acquired Neurotech
St Jude Medical Acquired Spinal Modulation
Orthofix International Acquired an Option to Acquire eNeura
Cyberonics Acquired Sorin
Medtronic Acquired Advanced Uro-Solutions
St. Jude Medical Acquired NeuroTherm
Sorin Acquired Neurotech
Greatbatch Acquired NeuroNexus Technologies
Boston Scientific Acquired Intelect Medical
TABLE 58 RECENT KEY STRATEGIC DEALS FOR NEUROMODULATION
MARKET
COMPETITIVE LANDSCAPE IN NEUROMODULATION
TABLE 59 GLOBAL MARKET FOR NEUROMODULATION DEVICES AND TECHNOLOGIES, BY LEADING COMPANIES, 2015 ($ MILLIONS)
FIGURE 31 GLOBAL MARKET SHARES OF NEUROMODULATION DEVICES AND TECHNOLOGIES, BY LEADING COMPANIES, 2015 (%)
OTHER NEUROMODULATION DEVICE TECHNOLOGIES
Directional DBS Lead (from St. Jude Medical)
Sentinel (from NeuroMetrix)
SurroGait Rx and Running Monitor (from Orpyx Medical Technologies)
Relay (from LivaNova)
Centro and CentroSR Generator (from LivaNova)
PhoenixRF SR and PhoenixRF NP (from LivaNova)
Cyberonics Accelerometer Device (from LivaNova)
SureSuite (from Medtronic)
Micropulse PNS Systems (from Medtronic)
OTHER EMERGING NEUROLOGY DEVICE TECHNOLOGIES
NOVUS SYSTEM (FROM BIONESS)
BMSEED MICROELECTRODE ARRAY (FROM BMSEED)
1x1 LIMITED TOTAL ENERGY TDCS (FROM ELECTRICAL GEODESICS)
ILLUMINA 3D NEURAL TARGETING SOFTWARE (FROM ILLUMINA)
Neuro-Spinal Scaffold (from InVivo Therapeutics)
Bioengineered Neural Tissue (from InVivo Therapeutics)
ProGuardian (from LivaNova)
Vivistim System (from MicroTransponder)
Neural Regeneration Product (from NanoNerve)
Soterix Mobile and HD-tDCS Software (from Soterix Medical)
SCS MRI Platform (from St. Jude Medical)
CHAPTER 6 EMERGING DEVICE TECHNOLOGIES IN DIABETES CARE
MARKET
DIABETES CARE DEVICES
EMERGING TECHNOLOGIES IN DIABETES MANAGEMENT
CONTINUOUS GLUCOSE MONITORING SYSTEMS (CGMS)
INSULIN PUMP
Traditional Insulin Pumps
Disposable Insulin Pumps
EPIDEMIOLOGY OF DIABETES
TYPE 1 DIABETES
TYPE 2 DIABETES
TABLE 60 GLOBAL PREVALENCE OF DIABETES, THROUGH 2040 ($ MILLIONS)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 61 GLOBAL MARKET FOR CGMS AND INSULIN PUMPS, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 32 GLOBAL MARKET SHARES OF CGMS AND INSULIN PUMPS, BY REGION, 2015 (%)
TABLE 62 GLOBAL MARKET FOR CGM SYSTEMS AND INSULIN PUMP, BY TYPE, 2015 ($ MILLIONS)
FIGURE 33 GLOBAL MARKET SHARES OF CGM SYSTEMS AND INSULIN PUMP, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
INSULIN PUMP INTEGRATION WITH CGM SYSTEMS
KEY MARKETED AND PIPELINE PRODUCTS
Recently FDA Approved Diagnostics
Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring
System (P120005/S031) (Dexcom)
R&D Pipeline Device Technologies
Enlite 3 (from Medtronic)
Libre Sensor (from Abbott)
T1D Management System (from Bigfoot Biomedical)
Next-Generation CGM Products (from DexCom)
GlySens ICGM System (from GlySens)
Patch Delivery System (from Medtronic)
MiniMed 670G (from Medtronic)
GlucoMen Day (from Menarini)
Eversense CGM System (from Senseonics)
TABLE 63 KEY R &D PIPELINE DEVICES FOR CGM SYSTEMS
Artificial Pancreas (from Bigfoot Biomedical)
ONETOUCH Ping Verio Insulin Pump with Meter Remote (from Johnson & Johnson)
MiniMed 620G Insulin Pump (from Medtronic)
Predictive Low Glucose Management Technology (PLGM) (from Medtronic)
t:sport Insulin Delivery System (from Tandem Diabetes Care)
Imperium (from Unilife)
TABLE 64 KEY R &D PIPELINE DEVICES FOR INSULIN PUMPS
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
COMPETITIVE LANDSCAPE IN THE CGM SYSTEM AND INSULIN PUMP MARKET
TABLE 65 GLOBAL MARKET FOR CGM SYSTEMS AND INSULIN PUMPS, BY LEADING COMPANIES, 2015 ($ MILLIONS)
FIGURE 34 GLOBAL MARKET SHARES OF CGM SYSTEMS AND INSULIN PUMPS MARKET BY LEADING COMPANIES, 2015 (%)
OTHER EMERGING DEVICE TECHNOLOGIES IN DIABETES CARE
Remote Diabetes Monitoring
Miniaturized Disposable Insulin Delivery Pumps
Glucose Sensing Bio-implants for Glucose Monitoring
Glucose Sensing Contact Lenses
Product using Near-Infra Red (NIR) Light to take Glucose Measurements
in the Body
Intraperitoneal Islet Transplantation
CHAPTER 7 EMERGING DIAGNOSTIC TECHNOLOGIES IN IN VITRO
DIAGNOSTICS MARKET
MOLECULAR DIAGNOSTICS
EMERGING CANCER MOLECULAR AND COMPANION DIAGNOSTICS
CANCER MOLECULAR DIAGNOSTICS
COMPANION DIAGNOSTICS
TABLE 66 COMMON COMPANION DIAGNOSTIC TESTS AND DRUGS
MARKET SIZE AND GROWTH ANALYSIS
TABLE 67 GLOBAL MARKET FOR CANCER MOLECULAR DIAGNOSTICS, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 35 GLOBAL MARKET SHARES OF CANCER MOLECULAR DIAGNOSTICS, BY REGION, 2015 (%)
TABLE 68 GLOBAL MARKET FOR CANCER MOLECULAR DIAGNOSTICS, BY TYPE, 2015 ($ MILLIONS)
FIGURE 36 GLOBAL MARKET SHARES OF CANCER MOLECULAR DIAGNOSTICS, BY TYPE, 2015 (%)
TABLE 69 GLOBAL MARKET FOR COMPANION DIAGNOSTICS, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 37 GLOBAL MARKET SHARES OF COMPANION DIAGNOSTICS, BY REGION, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND PIPELINE PRODUCTS
Recently FDA Approved Diagnostics
cobas KRAS Mutation Test (P140023) (Roche)
VENTANA ALK (D5F3) CDx Assay (P140025) (Ventana Medical Systems)
R&D Pipeline Device Technologies
ApoStream (from ApoCell)
"No Cell Left Behind" Platform (from Epic Sciences)
Genomic Bladder Cancer Liquid Biopsy Test (from Genomic Health)
Oncotype SEQ Liquid Mutation Panel (from Genomic Health)
Second-Generation Assay for Prostate Cancer (from Metamark Genetics)
Xpert Tests (from Cepheid)
Annexin A3 (from bioMérieux)
myPlan Renal Cancer, myPath Prostate Cancer, myPath Pancreatic
Cancer (from Myriad Genetics)
OncoCEE (from Biocept)
TABLE 70 KEY R &D PIPELINE DIAGNOSTICS AND TECHNOLOGIES
FOR CANCER MOLECULAR DIAGNOSTICS
Companion Diagnostic for Investigational anti-PD-L1 Antibody (from Agilent Technologies)
Glesatinib Companion Diagnostic Test (from Foundation Medicine)
Companion Diagnostic Test [Non-Small Cell Lung Cancer] (from QIAGEN)
Next-generation Sequencing (NGS) Oncology Test (from Thermo Fisher Scientific)
TABLE 71 KEY R &D PIPELINE DIAGNOSTICS AND TECHNOLOGIES FOR COMPANION DIAGNOSTICS
STRATEGIC DEALS (KEY MERGERS AND ACQUISITIONS)
Cancer Genetics acquired Response Genetics
Predictive Technology Group acquired Predictive Therapeutics - Remaining Shares
Biovica acquired cSens
Sysmex acquired Indivumed's Inostics and Inostics Inc. Subsidiaries
(Germany, U.S.)
Nuclea Biotechnologies acquired Wilex's U.S. Subsidiary
TABLE 72 RECENT KEY STRATEGIC DEALS FOR MOLECULAR
DIAGNOSTICS MARKET
COMPETITIVE LANDSCAPE IN ADVANCED CANCER MOLECULAR
DIAGNOSTICS
TABLE 73 GLOBAL MARKET FOR ADVANCED CANCER MOLECULAR
DIAGNOSTICS AND TECHNOLOGIES, BY LEADING COMPANIES, 2015
FIGURE 38 GLOBAL MARKET SHARES OF ADVANCED CANCER MOLECULAR DIAGNOSTICS AND TECHNOLOGIES, BY LEADING COMPANIES, 2015 (%)
OTHER EMERGING DIAGNOSTICS AND TECHNOLOGIES
Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV
(P140021) (Roche)
Gastric Emptying Breath Test (GEBT) (P110015) (Advanced Breath Diagnostics)
cobas HBV (P150014) (Roche)
cobasHCV Test (P150015) (from Roche)
PD-L1 IHC 28-8 pharmDx (P150025) (from Dako North America)
POINT-OF-CARE (POC) DIAGNOSTICS
POC AND CANCER
MARKET SIZE AND GROWTH ANALYSIS
TABLE 74 GLOBAL MARKET FOR POC DIAGNOSTICS, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 39 GLOBAL MARKET SHARES OF POC DIAGNOSTICS, BY REGION, 2015 (%)
TABLE 75 GLOBAL MARKET FOR POC DIAGNOSTICS, BY TYPE, 2015 ($ MILLIONS)
FIGURE 40 GLOBAL MARKET SHARES OF POC DIAGNOSTICS, BY TYPE, 2015 (%)
Market Growth Drivers and Restraints
KEY MARKETED AND PIPELINE PRODUCTS
Recently FDA Approved Diagnostics
cobas KRAS Mutation Test (P140023) (Roche)
Atlas io Platform - Nucleic Acid Detection (from Consort Medical)
POC Hemorrhagic Fever Test (from Lucigen)
Portable POC System (from Ohmx)
Blood Tests for Mild Traumatic Brain Injuries (from Abbott Laboratories)
Alere q Analyzer (from Alere)
Handheld Biosensor Reader (from Ohmx)
OraQuick Ebola Rapid Antigen Test (from OraSure Technologies)
Liat Dengue Assay (from Roche)
Rinse and Spit Test (from Vigilant Biosciences)
TABLE 76 KEY R &D PIPELINE DIAGNOSTICS AND TECHNOLOGIES FOR POC DIAGNOSTICS
Key R&D Pipeline Diagnostics
STRATEGIC DEALS (RECENT KEY MERGERS AND ACQUISITIONS)
Sinocare acquired PTS Diagnostics
Abbott Laboratories acquiring Alere
Roche acquired IQuum
EKF Diagnostics acquired DiaSpect Medical
Becton Dickinson acquired Alverix
Radiometer Medical acquired Quest Diagnostics' HemoCue Business
Agenix acquired Diagnostic Technology from Tyrian
TABLE 77 RECENT KEY STRATEGIC DEALS FOR POC DIAGNOSTICS
COMPETITIVE LANDSCAPE IN POC DIAGNOSTICS
TABLE 78 GLOBAL MARKET FOR POC DIAGNOSTICS AND TECHNOLOGIES, BY LEADING COMPANIES, 2015 ($ MILLIONS)
FIGURE 41 GLOBAL MARKET SHARES OF MOLECULAR DIAGNOSTICS DEVICE TECHNOLOGIES, BY LEADING COMPANIES, 2015 (%)
FUTURE OUTLOOK OF POC
CHAPTER 8 NEEDLE-FREE DRUG DELIVERY TECHNOLOGIES
NEEDLE-FREE DRUG DELIVERY TECHNOLOGIES
MARKET SIZE AND GROWTH ANALYSIS
TABLE 79 GLOBAL MARKET FOR NEEDLE-FREE DRUG DELIVERY TECHNOLOGIES, BY REGION, THROUGH 2021 ($ MILLIONS)
FIGURE 42 GLOBAL MARKET SHARES OF NEEDLE-FREE DRUG DELIVERY TECHNOLOGIES, BY REGION, 2015 (%)
MARKETED AND R&D PIPELINE PRODUCTS
KEY MARKETED PRODUCTS
Medi-Jector Vision Needle-Free Injector
Vibex Pressure Assisted Auto Injection System
Antares Pen Injector
Otrexup
Sumavel DosePro Needle-Free Delivery System
Biojector 2000 Needle-Free Injection System
Cool.click Needle-Free Injection System
AdvantaJet
PenJet Needle-Free System
Stratis Needle-Free System
Mini-Ject Needle-Free System
h-Patch
Micro-Trans
Short-Acting Bronchodilators
Corticosteroids
R&D PIPELINE PRODUCTS
Lapas (from Consort Medical)
Automated Reconstitution Auto Injector and Bespak Semi-Disposable
Auto Injector (from Consort Medical)
RITA Autoinjector (from Unilife)
LISA Autoinjector (from Unilife)
Nanopatch (from Vaxxas)
WindGap Medical Pre-Filled Automatic Injection Device (from WindGap Medical)
DEV200 Nicotine Inhaler Device (from Consort Medical)
CHAPTER 9 EMERGING DEVICE TECHNOLOGIES IN GI ENDOSCOPY
MARKET
SMART PILLS AND TECHNOLOGIES
CAPSULE ENDOSCOPY
MARKET SIZE AND GROWTH ANALYSIS
TABLE 80 GLOBAL MARKET FOR SMART PILLS AND TECHNOLOGIES, THROUGH 2021 ($ MILLIONS)
CURRENT DEVELOPMENTS AND R&D PIPELINE PRODUCTS
PillCam for Ulcerative Colitis/Crohn's Disease (from Medtronic)
PillCam SBC System (from Medtronic)
INTRAGASTRIC BALLOON SYSTEMS
OBESITY AND NEED OF INTRAGASTRIC BALLOONS
Growing Obesity Populations Worldwide
TABLE 81 TRENDS IN OBESITY COMPOSITION OF THE WORLD POPULATION, THROUGH 2020 ($ MILLIONS)
TABLE 82 U.S. OBESITY AND SEVERE OBESITY VS. GENERAL POPULATION, THROUGH 2020 (MILLIONS)
MARKET SIZE AND GROWTH ANALYSIS
TABLE 83 GLOBAL MARKET FOR INTRAGASTRIC BALLOON SYSTEMS, THROUGH 2021 ($ MILLIONS)
MARKETED AND R&D PIPELINE PRODUCTS
Recently FDA Approved devices
ORBERA Intragastric Balloon System (P140008) (Apollo Endosurgery)
ReShape Integrated Dual Balloon System (P140012) (ReShape Medical)
R&D Pipeline Products
Digestible Balloon (from PlenSat)
Digestible Balloon (from Tulip Medical)
Spatz3 Adjustable Balloon
Silimed Gastric Balloon (from Sientra)
CHAPTER 10 OTHER EMERGING MEDICAL DEVICE TECHNOLOGIES
IOL AND CORNEA IMPLANTS
MARKET SIZE AND GROWTH ANALYSIS
TABLE 84 GLOBAL MARKET FOR IOL, BY REGION, THROUGH 2021 ($ MILLIONS)
MARKETED AND R&D PIPELINE PRODUCTS
Recently FDA Approved Devices
KAMRA Inlay (P120023) (AcuFocus)
AcrySof IQ ReSTOR +2.5 D Multifocal IOL, Model SV25T0
(P040020/S050) (Alcon Laboratories)
R&D Pipeline Products
Mirricon (from ClearSight Innovations)
Actalens (from Emmetrope)
ClearSight IOL (from ClearSight)
AcrySof IQ, ReSTOR Toric IO (from Novartis)
PRIMA System (from Pixium Vision)
CATARACTS AND IOL
STANDARD MONOFOCAL VS PREMIUM IOLS
ADVANCED WOUND MANAGEMENT
ADVANCED WOUND DRESSINGS
NEGATIVE PRESSURE WOUND THERAPY
MARKET SIZE AND GROWTH ANALYSIS
TABLE 85 GLOBAL MARKET FOR ADVANCED WOUND MANAGEMENT (AWM) DEVICE TECHNOLOGIES, BY TYPE, THROUGH 2021 ($ MILLIONS)
MARKETED AND R&D PIPELINE PRODUCTS
Recently FDA Approved Devices
Progel Pleural Air Leak Sealant (P010047/S036) (NeoMend)
Adherus AutoSpray Dural Sealant (P130014) (HyperBranch Medical Technology)
R&D Pipeline Products
Senna (from BioRegen Biomedical)
Progell Vascular Sealant (from C. R. Bard)
Endomedix Hydrogel Sealant (from Endomedix)
Endomedix Topical Hemostat (from Endomedix)
Endomedix Wound Care (from Endomedix)
Scaffolene Plus GDF-5 (from Freudenberg)
Fibrin Sealant Grifols (from Grifols)
EpiBurn (from MiMedx Group)
Leia Dressings (from Mölnlycke Health Care)
IMPLANTABLE DRUG DIFFUSION PUMPS
KEY R&D PIPELINE DEVICE TECHNOLOGIES
Implantable Drug Delivery System (IDDS) (from Palyon Medical)
Micro-Dosing System (from Palyon Medical)
ENDOLUMINAL PROCEDURES
MULTIPARAMETER VITAL SIGNS MONITORS
NONINVASIVE BLOOD PRESSURE (NIBP) MONITORS
HEMODIALYSIS AND PERITONEAL DIALYSIS
HEMODIALYSIS
PERITONEAL DIALYSIS
BIOCHIPS ARE MICROCHIP-BASED SENSORS
EAR IMPLANTS
KEY R&D PIPELINE PRODUCTS
Cochlear Nucleus Hybrid S12 (from Cochlear)
Nucleus CI532 Cochlear Implant (from Cochlear)
AventaMed ENT Device (from AventaMed)
MAMMOGRAPHY
RECENTLY FDA APPROVED DEVICES
MAMMOMAT Inspiration with Tomosynthesis (P140011) (Siemens Medical)
ROBOTICS AND COMPUTER-ASSISTED SURGERY
SURGICAL PLANNERS AND SIMULATORS
SURGICAL NAVIGATION SYSTEMS
SURGICAL ROBOTS
DIGITAL OPERATING ROOMS AND EQUIPMENT
SURGICAL LASERS
MARKETED AND R&D PIPELINE PRODUCTS
Recently FDA Approved Devices
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan
Studio System (P930016/S044) (AMO Manufacturing)
R&D Pipeline Products
Next-generation Laser (from AngioDynamics)
StarFire Laser (from Boston Scientific)
POSITRON EMISSION TOMOGRAPHY
KEY PRODUCTS
Biograph mMR Whole-Body Integrated MR-PET System
PET + MR Sequential Imaging System
OPTICAL IMAGING
TIME DOMAIN (TD) OPTICAL IMAGING
CT LASER MAMMOGRAPHY (CTLM)
OPTICAL COHERENCE TOMOGRAPHY (OCT)
SCANNING LASER POLARIMETRY (SLP)
SCANNING LASER OPTHALMOSCOPY (SLO)
FLUORESCENCE SPECTROSCOPY
OTHER FDA APPROVED AND R&D PIPELINE DEVICE TECHNOLOGIES
RESQCPR SYSTEM: RESQPUMP (ACD-CPR DEVICE) AND RESQPOD ITD 16 (P110024) (ADVANCED CIRCULATORY SYSTEMS)
LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN (H130001) (KANEKA PHARMA AMERICA)
REJIVA (FROM RIJUVEN)
VENASEAL CLOSURE SYSTEM (P140018) (COVIDIEN)
ASPIREASSIST (P150024) (FROM ASPIRE BARIATRICS)
ENTEROMEDICS MAESTRO RECHARGEABLE SYSTEM (P130019) (FROM ENTEROMEDICS)
CIRLE SURGICAL NAVIGATION SYSTEM (FROM VALEANT
PHARMACEUTICALS INTERNATIONAL)
CHAPTER 11 REGULATORY STRUCTURE
UNITED STATES
EUROPEAN UNION
TABLE 86 DIFFERENCES IN REGULATORY APPROVAL IN THE U.S. VS.
EUROPE
JAPAN
OTHER ASIA
CHINA
Hong Kong
KOREA
TAIWAN
INDIA
FDA TECHNICAL CONSIDERATIONS
FDA RECALLS AND SAFETY ALERTS
CHAPTER 12 PRICING AND REIMBURSEMENT
UNITED STATES
ICD-9-CM
ICD-10
EUROPE
JAPAN
OTHER ASIA
CHAPTER 13 CONCLUSIONS: OUTLOOK FOR EMERGING MEDICAL
DEVICE TECHNOLOGIES
MAJOR DEVELOPMENTS TO INFLUENCE MARKET
TECHNOLOGICAL DEVELOPMENTS: ADAPTATION OF MINIMALLY INVASIVE AND NON-INVASIVE TECHNIQUES
DEMOGRAPHIC AND ECONOMIC TRENDS: INCOME GROWTH IN DEVELOPING MARKETS
TABLE 87 TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION, 2012-2015 (ANNUAL AVERAGE PERCENTAGE CHANGE)
CHANGING STRUCTURE OF THE HEALTH CARE INDUSTRY
Hospital Consolidation
Medical Tourism
Health Insurance Developments
LONG-TERM OUTLOOK FOR EMERGING MEDICAL DEVICE TECHNOLOGIES
CHAPTER 14 COMPANY PROFILES
3M
480 BIOMEDICAL
ABBOTT LABORATORIES
ACCUMED SYSTEMS INC.
AC-GEN READING LIFE
ACTUATED MEDICAL
ADIENT MEDICAL
ADVANCED RESEARCH TECHNOLOGIES INC.
AEGERIA SOFT TISSUE
AETHLON MEDICAL INC.
AFREEZE
ALERE INC.
ALLERGAN PLC
ALLURION TECHNOLOGIES
AMARANTH MEDICAL
A.M.I. (AGENCY FOR MEDICAL INNOVATIONS)
ANGIODYNAMICS
APAMA MEDICAL
APPLIED MEDICAL
APOLLO ENDOSURGERY
APOCELL
ASPIRE BARIATRICS
ATRICURE
AUDAX MEDICAL
BARD
BARONOVA
BAROSENSE (SUBSIDIARY OF BOSTON SCIENTIFIC)
BAXTER INTERNATIONAL INC.
BELLEROPHON THERAPEUTICS
BETA-STIM LTD.
BFKW
BIOCEPT
BIOMERIEUX
BIONESS
BIO-SCAFFOLD INTERNATIONAL
BIOSENSE WEBSTER INC. (SUBSIDIARY OF JOHNSON & JOHNSON)
BIOSURFACE ENGINEERING TECHNOLOGIES
BIOTHERANOSTICS
BIOTRONIK
BOSTON SCIENTIFIC CORP.
BRACCO
CALLISYN BIOMEDICAL INC.
CARDIOSOLUTIONS INC.
CARDIOVASCULAR SYSTEMS INC.
CARMELL THERAPEUTICS CORP.
CERVEL NEUROTECH
COLIBRI HEART VALVE
COOK GROUP INC.
CONSORT MEDICAL
CORAMAZE TECHNOLOGIES GMBH
CORAS MEDICAL
CROSPON
CVTEC CEREBROVASCULAR TECHNOLOGIES
EDWARDS LIFESCIENCES
ELECTRICAL GEODESICS INC.
ELIXIR MEDICAL
ENDOBETIX
ENDOGASTRIC SOLUTIONS
ENDOLOGIX
ENDORETICS INC.
ENDOSPHERE
ENDOSPAN
ENTEROMEDICS INC.
GAUDI VASCULAR
GELESIS
GENTIS
GETINGE AB
GI DYNAMICS
GI WINDOWS INC.
GREATBATCH
GUIDED DELIVERY SYSTEMS
HANSEN MEDICAL INC.
HARPOON MEDICAL
HEARTWARE
HELIOSCOPIE
HOLOGIC
ICELLATE
ILLUMINA
IMPLANTS INTL.
INIVATA LTD.
INSPIREMD
INTEGRA LIFESCIENCES
INTERFACE BIOLOGICS
INTRAPACE INC.
INVIVO THERAPEUTICS CORP.
JENAVALVE TECHNOLOGY
KEYSTONE HEART
LIFETECH SCIENTIFIC
LIVANOVA
LOMBARD MEDICAL TECHNOLOGIES
LONESTAR HEART INC.
LUCIGEN
MAINSTAY MEDICAL
MEDTRONIC
METACURE
METAMARK GENETICS
MICARDIA CORP.
MICROPORT SCIENTIFIC
MICROTRANSPONDER
MINDRAY MEDICAL INTERNATIONAL LTD.
MIRACA HOLDINGS
MITRASSIST
MSDX INC.
MYRIAD GENETICS INC.
NANONERVE INC.
NEOVASC
NESHER TECHNOLOGIES INC.
NEUROMETRIX
NEURORECOVERY TECHNOLOGIES
NOVARTIS
OBALON THERAPEUTICS
OHMX
ONCIOMED INC.
ONCOGENESIS
OPTO CIRCUITS (INDIA) LTD.
ORASURE TECHNOLOGIES
ORPYX MEDICAL TECHNOLOGIES INC.
ORTHOFIX INTL.
OSTEOTEC LTD.
PALMAZ SCIENTIFIC INC.
PENUMBRA
PLENSAT INC.
QUANTERIX CORP.
RENISHAW
RESHAPE MEDICAL
REVA MEDICAL INC.
RIJUVEN
SARL COUSIN BIOTECH
SATIETY INC.
SCIENTIFIC INTAKE
SENSATE
SETPOINT MEDICAL
SHAPE MEMORY MEDICAL INC.
SKLAR CORP.
SLIMEDICS LTD.
SMITH & NEPHEW
SOFT TISSUE REGENERATION INC.
SOTERIX MEDICAL INC.
SPATZ FGIA
SPECTRANETICS
ST. JUDE MEDICAL
STRYKER
SYMETIS
SYSMEX CORP.
TAL MEDICAL
TERUMO CORP.
TISSUE REGENERATION SYSTEMS
TISSUE REGENIX GROUP PLC
TOMOWAVE LABORATORIES
TORNIER INC.
TRANSCATHETER TECHNOLOGIES
TRANSENTERIX
TRIVITRON HEALTHCARE
TTK HEALTHCARE
TULIP MEDICAL LTD.
USGI MEDICAL
VALEANT PHARMACEUTICALS INTL.
VALENTX
VIGILANT BIOSCIENCES
W. L. GORE AND ASSOCIATES
WRIGHT MEDICAL TECHNOLOGY INC.
XELTIS
YPSOMED HOLDING AG
ZIMMER BIOMET
CHAPTER 15 APPENDIX A INDUSTRY AND PROFESSIONAL
ORGANIZATIONS
AMERICAN ASSOCIATION FOR CANCER RESEARCH (AACR)
AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE (ASRM)
AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO)
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
CENTERS FOR MEDICARE & MEDICAID SERVICES
EUDAMED
FOOD AND DRUG ADMINISTRATION (FDA)
GLOBAL CANCER FOUNDATION
HORMONE FOUNDATION
INTERNATIONAL AGENCY FOR RESEARCH ON CANCER
INTERNATIONAL FEDERATION OF PHARMACEUTICAL MANUFACTURERS & ASSOCIATIONS (IFPMA)
INTERNATIONAL OSTEOPOROSIS FOUNDATION (IOF)
INTERNATIONAL DIABETES FEDERATION (IDF)
NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION (NCBI)
NATIONAL INSTITUTE OF AGING (NIA)
PMDA
WORLD CANCER RESEARCH FUND INTERNATIONAL
CHAPTER 16 APPENDIX B: ABBREVIATIONS


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