THIS REPORT: 

Analysis of the technologies for five areas of drug-device combination products, including antimicrobial catheters, biologic wound care products, bone graft substitutes and bone cements, drug-eluting stents and photodynamic therapy (PDT)

Analysis of global markets with data for 2008, estimates for 2009, and projections of 5-year compound annual growth rates through 2014

Detailed discussion of the current regulatory environment for drug-device combination products and how this is affecting development and approval of such devices

Further analysis of overall market trends and competitors, and profiles of selected competitors in the category.

Table Of Contents

CHAPTER ONE: INTRODUCTION .. 1

STUDY GOALS AND OBJECTIVES .... 1
REASONS FOR DOING THIS STUDY AND ITS IMPORTANCE ..... 1
INTENDED AUDIENCE .......... 2
SCOPE AND FORMAT OF REPORT ... 2
METHODOLOGY AND INFORMATION SOURCES ......... 2
ANALYST CREDENTIALS ...... 3
BCC ONLINE SERVICES ........ 3
DISCLAIMER .......... 4

CHAPTER TWO: EXECUTIVE SUMMARY .. 5

SCOPE OF THE INDUSTRY ... 5
DRUG-DEVICE COMBINATIONS: THE GLOBAL MARKET ........... 5
TECHNOLOGY AND PATENT ACTIVITY ........... 6
THE CENTRAL ROLE OF THE FDA .. 6
SUMMARY TABLE SALES OF DRUG DEVICE COMBINATION
PRODUCTS, THROUGH 2014 ($ BILLIONS) ..... 7
SUMMARY FIGURE SALES OF DRUG DEVICE COMBINATION
PRODUCTS, 2008-2014 ($ BILLIONS) . 8

CHAPTER THREE: CURRENT STATUS OF THE DRUG DEVICE

COMBINATION INDUSTRY ........ 9
OVERVIEW . 9
ROLE OF THE FDA 9
TABLE 1 RECENT EXAMPLES OF FDA APPROVED COMBINATION
PRODUCTS 10
TABLE 1 (CONTINUED) . 11
OFFICE OF COMBINATION PROUCTS ORGANIZATIONAL
STRUCTURE .... 11
HIGHLY ADVANCED TECHNOLOGIES ARE A MARKET CORE 11
EXAMPLES OF THE MOST PATH-BREAKING PRODUCTS ......... 12
FDA CLASSIFICATION SCHEME FOR INDIVIDUAL SEGMENTS .......... 13
TABLE 2 FDA CLASSIFICATION SCHEME FOR COMBINATION
PRODUCTS 14
THE RELATION BETWEEN NANOTECHNOLOGY AND
COMBINATION PRODUCTS ........ 14
FDA TRENDS IN REVIEWING COMBINATION PRODUCTS ....... 14
FIGURE 1 COMBINATION PRODUCT APPLICATIONS AT FDA, 2003-
2007 (NUMBER OF SUBMISSIONS) . 15
TABLE 3 FDA COMBINATION PRODUCT CATEGORIES, FY 2004 .. 16
TABLE 4 FDA COMBINATION PRODUCT CATEGORIES, FY 2005
(NUMBERS AND TYPES OF COMBINATION PRODUCTS) .......... 17

CHAPTER FOUR: REGULATORY PROCESS AND ISSUES ... 18

OVERVIEW ............ 18
SCOPE OF FDA ACTION ...... 18
TREATMENT OF DEVICES .. 19
CLASS I DEVICES ...... 19
CLASS II DEVICES ..... 19
CLASS III DEVICES ... 20
CURRENT STATUS OF FDA AND NANOTECHNOLOGY
INITIATIVES .... 21
FDA NANOTECH PRODUCT APPROVALS ....... 21
OTHER RELEVANT HEALTH OR REGULATORY AGENCIES ..... 22
TYPICAL REGULATORY MILESTONES IN COMBINATION
PRODUCT APPROVALS .. 23
CLINICAL TRIALS ... 24

CHAPTER FIVE: NANOTECH COMBINATION PRODUCTS . 25

OVERVIEW ............ 25
NATIONAL NANOTECHNOLOGY INITIATIVE (NNI) .. 25
NANOTECH REGULATORY ENVIRONMENT .. 26
NANOTECH REGULATORY ENVIRONMENT (CONTINUED) ....... 27
COMBINATION NANOTECHNOLOGY PRODUCT RESEARCH ... 28
NANODIAMOND DRUG DEVICES FOR CANCER
TREATMENT .......... 29
NANOTECHNOLOGY-MAGNETISM COMBINATION IN TINY
IMPLANTABLE DEVICE FOR DRUG DELIVERY .......... 30
IMPLANTS USING CONDUCTING POLYMER NANOTUBES ........ 31
CALCIUM PHOSPHATE NANOPARTICLES FOR DRUG
DELIVERY . 32
NANO-SCALE DELIVERY OPTIMIZES CHEMOTHERAPY
REGIMES ... 33
DRUG INFUSED NANOPARTICLES ....... 34
Drug Infused Nanoparticles (Continued) ..... 35
ENCAPSULATION OF DRUG TREATMENTS IN
NANOPARTICLES . 36
SILICON NANOWIRES FOR DRUG DELIVERY . 36
MINUTE ANTIBACTERIAL PARTICLES DESTROY DRUGRESISTANT
GERMS .......... 37
BIODEGRADABLE CATIONIC CORE-SHELL
NANOPARTICLES FOR CO-DELIVERY OF DRUGS AND
GENES ... 38
STIMULI-SENSITIVE CORE-SHELL NANOPARTICLES FOR
CANCER THERAPY ............ 38
POLYMER-BASED NON-VIRAL GENE CARRIERS 39
POTENTIAL HEALTH EFFECTS: IMPACT ON NANO INDUSTRY .......... 39
POTENTIAL HEALTH EFFECTS: … (CONTINUED) ........... 40
TABLE 5 REVENUES ATTRIBUTABLE TO NANOTECHNOLOGYBASED
DRUG-DEVICE COMBINATIONS, THROUGH 2014 $
MILLIONS . 41

CHAPTER SIX: DRUG-ELUTING CORONARY STENTS ........ 42

OVERVIEW ............ 42
DEFINITION AND SIZE OF TARGET MARKET ............ 42
TABLE 6 MARKETS FOR CORONARY STENTS, THROUGH 2014 $
BILLIONS .. 43
STENT MARKET REINFORCED BY CURRENT RESEARCH
FINDINGS ........ 43
STENT MARKET REINFORCED …(CONTINUED) 44
STENT MARKET REINFORCED …(CONTINUED) 45
PRINCIPAL DRUG-ELUTED STENT PRODUCERS ...... 46
STENT DESIGN .... 46
PRODUCT LINES . 47
PRODUCT LINES (CONTINUED) ............ 48
MECHANISM OF ACTION ... 49
DEVELOPMENT OF THE INDUSTRY .. 49
FDA REGULATORY ROLE WITH REGARD TO STENTS . 49
FDA REGULATORY ROLE … (CONTINUED) ..... 50
TABLE 7 EXAMPLES OF STENTS APPROVED FOR CLINICAL USE ........... 51
TABLE 7 (CONTINUED) . 52
STENT PRODUCT INNOVATIONS AND RandD: BIOABSORBABLE
STENTS ............ 52
BIODEGRADABLE COATINGS ... 53
HYDROXYAPATITE COATINGS . 53
Hydroxyapatite Coatings (Continued) .......... 54
MARKETS FOR STENT RELATED TECHNOLOGIES .. 55
LIPISCAN CORONARY IMAGING SYSTEM ........ 55
LipiScan Coronary Imaging System (Continued) ........ 56

CHAPTER SEVEN: PHOTODYNAMIC THERAPY ...... 57

OVERVIEW ............ 57
TREATMENT LIMITATIONS ............ 57
TECHNOLOGY HISTORY ..... 58
RECENT DEVELOPMENTS . 58
SECOND GENERATION PDT SENSITIZERS .... 59
PDT MARKETS FOR CANCER .......... 59
PDT MARKETS FOR MACULAR DEGENERATION ...... 60
PDT MARKETS FOR PSORIASIS ...... 61
TYPES OF UVB THERAPY FOR PSORIASIS ....... 61
PUVA PHOTOCHEMOTHERAPY 62
TARGETED PHOTOTHERAPY (EXCIMER LASER) ............ 62
OTHER MEDICAL APPLICATIONS . 63
PDT MARKET GROWTH DRIVERS .. 63
EXAMPLE PDT PRODUCTS . 64
VISUDYNE (NOVARTIS) ......... 64
LEVULAN ... 65
PHOTOFRIN (PORFIMER SODIUM) ....... 65
VISONAC ..... 65
CEVIRA ....... 66
LUMACAN .. 66
RESEARCH AND DEVELOPMENT .. 66
INTERVENTIONAL CARDIOLOGY ......... 66
DERMATOLOGY ......... 67
AUTOIMMUNE DISEASES ..... 67
EQUIPMENT PRODUCERS .. 68
TABLE 8 PHOTODYNAMIC THERAPY MARKETS, THROUGH 2014
($BILLIONS) ........... 68

CHAPTER EIGHT: ANTIMICROBIALS AND OTHER MEDICAL DEVICE

COATINGS ..... 69
OVERVIEW: REGULATORY TREATMENT ....... 69
DRIVING FORCE IN DEVELOPMENT OF ANTI-MICROBIALS ... 69
DRIVING FORCE IN … (CONTINUED) ... 70
MARKET CONTEXT AND PREVALENCE OF INFECTIONS ........ 71
EXAMPLES OF USE . 72
TRENDS IN FDA APPLICATIONS FOR ANTIMICROBIALS ......... 73
TABLE 9 REVENUES ATTRIBUTABLE TO ANTIMICROBIALS
THROUGH 2014 ($ BILLIONS) .......... 73
ANTI-MICROBIAL AND OTHER MEDICAL DEVICE COATINGS 73
MARKET CATEGORIES FOR MEDICAL DEVICE COATINGS IN
COMBINATION PRODUCTS ........ 74
TABLE 10 REVENUES ATTRIBUTABLE TO MEDICAL DEVICE
COATINGS THROUGH 2014 ($ MILLIONS) ....... 75
EXAMPLE PRODUCTS ......... 75
TABLE 11 MEDICAL DEVICE PRODUCTS RELYING ON
ANTIMICROBIAL COATINGS ............ 75
TABLE 11 (CONTINUED) ............ 76

CHAPTER NINE: ANTIMICROBIAL CATHETERS .... 77

MARKET OVERVIEW ........... 77
APPLICATIONS .... 77
MARKET SIZE ....... 78
CATHETER INNOVATIONS . 78
ANTIMICROBIAL CATHETER CONCEPTS ...... 79
EXAMPLE PRODUCTS ......... 80
5-FLUOROURACIL-COATED CENTRAL VENOUS
CATHETER 80
DRUG - DEVICE COMBINATION CATHETER LOCK/FLUSH
SOLUTIONS ........... 81
RandD INITIATIVES 81
DIALYSIS CATHETERS .......... 81
URINARY CATHETERS .......... 82
OTHER DELIVERY TECHNIQUES .......... 83
TABLE 12 CATHETER MARKET FORECASTS, BY PRODUCT TYPE,
THROUGH 2014 ($ BILLIONS) .......... 84

CHAPTER TEN: DRUG-ELUTING BEADS 85

OVERVIEW ............ 85
EXAMPLE OF THERAPY ...... 85
COMPANY ACTIVITY ........... 85
COMPANY ACTIVITY (CONTINUED) ..... 86
BEAD APPLICATIONS IN STROKE . 87
BEAD APPLICATIONS IN ALLERGY AND ASTHMA ATTACKS .. 87
RECENT FDA APPROVALS .. 88
RECENT OVERSEAS APPROVALS .. 89
CLINICAL TRIALS ... 90
TABLE 13 CURRENT CLINICAL TRIALS INVOLVING DRUGELUTING
BEADS .. 91
TABLE 13 (CONTINUED) ............ 92
RandD AND OTHER NOVEL APPLICATIONS OF BEADS .. 93
USING FLUORESCENT SILICA BEADS TO DETECT
MALIGNANT CERVICAL CELLS ....... 93
ANTIBODY COATED MAGNETIC BEADS TO COMBAT
INFECTION ............ 94
FUMAGILLIN NANOPARTICLES ............ 94
Fumagillin Nanoparticles (Continued) ......... 95
CONTROLLED DELIVERY OF TUMOR-KILLER DRUGS 96
POLYMERIC MICROCAPSULES 97
TABLE 14 RandD AND REVENUES ATTRIBUTABLE TO DRUGELUTED
BEADS, THROUGH 2014 ($ MILLIONS) ......... 98

CHAPTER ELEVEN: BONE CEMENTS INCLUDING ANTIBIOTIC ...... 99

OVERVIEW ............ 99
EARLY HISTORY 100
APPLICATIONS .. 100
MARKET SIZE ..... 101
COMPOSITION ... 101
EXAMPLE PRODUCTS ....... 102
RELATED PRODUCTS: TYPES OF CERAMICS ........... 103
ALPHA-BSM . 104
BIOGRAN .. 104
BIO-OSS .... 104
BONESOURCE .......... 105
CALCIGEN S . 105
CEMENTS IN DENTAL APPLICATIONS: GLASS IONOMER
CEMENTS ...... 105
OTHER OSTEOCONDUCTIVE BONE GRAFT SUBSTITUTES ... 106
OTHER OSTEOCONDUCTIVE BONE … (CONTINUED) .. 107
CHAPTER TWELVE: BONE GRAFT SUBSTITUTES ............ 108
OVERALL SIZE OF BONE GRAFT BUSINESS ............ 108
BONE GRAFT SUBSTITUTES ......... 109
ALLOGRAFT TISSUE ............ 110
OTHER OSTEOCONDUCTIVE BONE-GRAFT SUBSTITUTES ..... 111
HYDROGELS IN BONE GRAFTING ...... 112
Composition and Method for Self-Assembly and
Mineralization of Peptide Amphiphiles . 113
Chondroitinase ABC I Polynucleotides ....... 114
Transdiscal Administration of Cycline Compounds .... 114
Composition and Method for Preparing Biocompatible
Surfaces ...... 114
Spinal Mobility Preservation Apparatus Having an
Expandable Membrane 115
OSTEOBIOLOGICS AND OSTEOINDUCTIVE GROWTH FACTORS ...... 115
BONE GRAFTS .... 116
TABLE 15 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL ....... 117
TABLE 16 BONE GRAFT PROCEDURE VOLUMES BY APPLICATION
IN THE U.S., THROUGH 2014 ......... 118
TABLE 17 BONE GRAFT PROCEDURE VOLUMES BY TYPE OF
GRAFT IN THE U.S., THROUGH 2014 . 118
TABLE 18 COMPARISON OF BONE GRAFT MATERIALS .. 119
TABLE 18 (CONTINUED) .......... 120
TABLE 19 TYPES OF SUBSTITUTE BONE GRAFTS ...... 120
TABLE 19 (CONTINUED) .......... 121
AUTOGRAFTS ........... 121
BioSeed Grafts . 121
Allografts .......... 122
Allografts (Continued) ......... 123
Allografts (Continued) ......... 124
Demineralized Bone Matrix Products ........ 125
TABLE 20 SELECTED DBM PRODUCT AND PERCENTAGE OF
DEMINERALIZED BONE MATRIX . 125
Accell ..... 126
AlphaGRAFT ...... 126
Allomatrix .......... 126
Grafton DBM ...... 126
DBX ....... 126
DynaBlast and DynaGraft-D ............ 126
Graftech . 127
Grafton .. 127
Opteform ............ 127
OrthoBlast II ...... 128
Osteofil .. 128
Solo Cervical Allograft ......... 128
Xenografts ........ 128
THE MARKET FOR ALLOGRAFTS ........ 129
TABLE 21 THE U.S. MARKET FOR PRECISION-MACHINED
ALLOGRAFTS, THROUGH 2014 ($ MILLIONS) ........... 129
CELL-BASED BONE GRAFT SUBSTITUTES .... 130
FACTOR-BASED BONE GRAFT SUBSTITUTES ... 131
BONE MORPHOGENIC PROTEINS ...... 132
InductOs ........... 133
INFUSE Bone Graft ..... 133
OP-1 Implant ... 133
CERAMIC-BASED BONE GRAFT SUBSTITUTES 134
TYPES OF CERAMICS .......... 135
Alpha-BSM ....... 135
BioGran ............ 136
Bio-Oss 136
BoneSource ...... 136
Calcigen S ........ 136
Collagraft Strip Bone Graft Matrix ............ 136
Conduit TCP Granules . 137
IsoTis Products 137
Mimix Bone Substitute Material ... 138
Norian SRS ...... 138
OsteoGraf ......... 138
Osteoset ............ 139
Osteostim Resorbable Bone Graft Substitute 139
PerioGlas .......... 139
Pro Osteon Implant ...... 139
Vitoss ... 139
POLYMER-BASED BONE GRAFT SUBSTITUTES ............ 140
Cortoss . 140
Healos .. 141
Immix Extenders and Immix CB ... 142
THE MARKET FOR BONE GRAFT PRODUCTS .......... 142
TABLE 22 THE WORLDWIDE MARKET FOR BONE REPLACEMENT
PRODUCTS, THROUGH 2014 ($ MILLIONS) ... 143
TABLE 23 THE U.S. MARKET FOR BONE REPLACEMENT
PRODUCTS, THROUGH 2014 ($ MILLIONS) ... 143
REGENERATIVE MEDICINE PRODUCTS IN DEVELOPMENT FOR
BONE APPLICATIONS .. 144
BIOLOGIC/SYNTHETIC GRAFTS .......... 144
CHRYSALIN . 145
Chrysalin (Continued) .. 146

CHAPTER THIRTEEN: WOUND CARE PRODUCTS INCLUDING

BIOLOGICAL DRESSINGS ...... 147
WOUND CARE GENERALLY .......... 147
MARKET SEGMENTS ......... 147
COLLAGEN ... 147
COLLAGEN IN MEDICAL APPLICATIONS ....... 148
TABLE 24 IDENTIFICATION OF COLLAGEN-BASED PRODUCTS ............ 149
SPECIFIC COLLAGEN PRODUCTS ...... 149
TenoMendTM Collagen Tendon Wrap ........ 150
CosmoDerm and CosmoPlast Human-Based Collagen ............ 150
TISSUE ENGINEERING ..... 150
SKIN SUBSTITUTES: CELLS AND TISSUES ... 150
ARTIFICIAL SKIN .... 151
TABLE 25 EXAMPLES OF SKIN SUBSTITUTE PRODUCTS ........... 152
SKIN-LIKE TISSUE DEVELOPED FROM HUMAN
EMBRYONIC STEM CELLS . 153
TABLE 26 TOTAL SALES OF ENGINEERED SKIN GRAFTS AND
REPLACEMENTS, THROUGH 2014 ($ MILLIONS) ..... 154
ALGINATES .. 155
TABLE 27 EXAMPLES OF ALGINATE-BASED PRODUCTS ............ 155
FIBRIN SEALANT PRODUCTS . 156
HISTORY OF FIBRIN SEALANTS ......... 156
PRODUCTS ... 157
Evicel ... 157
Artiss ... 157
ReCell .. 158
RELATED PRODUCTS: FIRST FDA APPROVED SPINE
SEALANT . 158
ENZYMATIC DEBRIDING AGENTS ...... 159
NANOSTRUCTURED TEMPERATURE-SENSITIVE
MEMBRANES FOR WOUND HEALING AND CELL
GRAFTING ........... 159
TABLE 28 EXAMPLE ENZYMATIC DEBRIDING AGENTS . 160
TABLE 29 MARKETS FOR BIOLOGICAL WOUND CARE PRODUCTS
THROUGH 2014 ($ BILLIONS) ........ 160

CHAPTER FOURTEEN: DRUG DEVICE COMBINATION PRODUCTS
FOR OCCULAR APPLICATIONS .......... 161

OVERVIEW .......... 161
INTRAOCULAR LENS PRODUCTS 161
LENS MATERIALS ... 162
CLEAR LENS EXTRACTION AND REPLACEMENT (CLEAR)
SURGERY 163
VITREOUS SUBSTITUTES ... 163
Polymers ........... 164
Perfluorocarbon Liquids (PFCL) .... 164
Silicone Oil ....... 165
Combination Product: PFCL and Silicone Oil 165
OCULAR DRUG DELIVERY VIA NANOSTRUCTURED
DRUG-LOADED CONTACT LENSES ............ 166
MARKET POTENTIAL ........ 167
TABLE 30 MARKETS FOR OCCULAR APPLICATIONS IN DRUGDEVICE
COMBINATION PRODUCTS, THROUGH 2014 ($
MILLIONS) ........... 167

CHAPTER FIFTEEN: IMPLANTABLES AS DRUG DEVICE

COMBINATIONS ...... 168
MINIATURE NEUROSTIMULATORS . 168
BIODEGRADABLE CIRCUITS ........ 168
BIODEGRADABLE CIRCUITS (CONTINUED) .. 169
STEROID ELUTING PACEMAKER LEADS ..... 170
MARKET SIZE ..... 171
TABLE 31 IMPLANTABLE DRUG DEVICE COMBINATIONS
THROUGH 2014 ($ MILLIONS) ........ 171
CHAPTER SIXTEEN: RELATED DRUG DEVICE COMBINATIONS OF
RELEVANCE ............ 172
OVERVIEW .......... 172
MARKET SIZE ..... 172
TABLE 32 MARKETS FOR RELATED DRUG-DEVICE COMBINATION
PRODUCTS, THROUGH 2014 ($ MILLIONS) . 172
INJECTABLE BIODEGRADABLE HYDROGELS FOR DRUG
DELIVERY AND TISSUE ENGINEERING . 173
RADIATION/DRUG COMBINATIONS . 173
ANTI-BACTERIAL RELEASING DENTAL RESTORATIVE
MATERIALS ... 174
COMBINATION DENTAL PROPHYLAXIS PASTES AND DRUG
COMPONENTS .. 174
METERED DOSE INHALERS, SPACERS AND OTHER
ACCESSORIES ... 175
METERED DOSE INHALERS, …(CONTINUED) ... 176
ANTIMICROBIAL SUTURES .......... 177
ANTIMICROBIAL VASCULAR GRAFTS .......... 178
HEAT-ACTIVATED DRUGS ............ 178
HEAT-ACTIVATED DRUGS (CONTINUED) ...... 179
BREATH TEST COMBINATION PRODUCTS .. 180
MYOCELL THERAPY BY BIOHEART, INC. .... 180
OTHER NEW DRUG DELIVERY CONCEPTS . 181
CHAPTER SEVENTEEN: PATENT ANALYSIS ......... 182
OVERVIEW .......... 182
OTHER INTELLECTUAL PROPERTY ISSUES ............ 182
EXAMPLE DRUG-DEVICE COMBINATION PATENTS: 2008 TO
2009 .... 183
ELECTROPROCESSED COLLAGEN AND TISSUE
ENGINEERING .... 183
BIOFUNCTIONAL, ANTIMICROBIAL COATINGS FOR
MEDICAL DEVICES ......... 183
GELATIN DERIVATIVES AND HIGH-MOLECULAR
MICELLE COMPRISING THE DERIVATIVES . 184
METHODS AND APPARATUS FOR ACUTE OR CHRONIC
DELIVERY OF SUBSTANCES OR APPARATUS TO
EXTRAVASCULAR TREATMENT SITES ...... 185
WOUND COVERING . 185
NANOPARTICLES FOR PROTEIN DRUG DELIVERY ...... 186
PROCESS FOR PROVIDING ANTIMICROBIAL SURFACES ......... 186
GROWTH FACTOR MODIFIED PROTEIN MATRICES FOR
TISSUE ENGINEERING .. 186
METHOD OF COATING IMPLANTABLE MEDICAL DEVICES .... 187
ANTIMICROBIAL COATING FOR EROSIVE
ENVIRONMENTS 187
METHOD AND COMPOSITION FOR PRODUCING
CATHETERS WITH ANTIBACTERIAL PROPERTY ..... 188
IMPLANTABLE MEDICAL DEVICE WITH ANTI-INFECTION
AGENT . 188
MINIATURE DRUG DELIVERY PUMP WITH A
PIEZOELECTRIC DRIVE SYSTEM .. 189
IONTOPHORESIS DEVICE ... 189
APPARATUS FOR COATING MEDICAL DEVICES ........... 189
COATINGS FOR DRUG DELIVERY DEVICES .. 190
THIN-FILM DRUG DELIVERY ARTICLE AND METHOD OF
USE ....... 190
IMPLANTABLE, TISSUE CONFORMING DRUG DELIVERY
DEVICE 191
IMPLANTABLE DEVICE WITH RESERVOIRS FOR
INCREASED DRUG LOADING ......... 191
STENT ASSEMBLY FOR THE TREATMENT OF
VULNERABLE PLAQUE .. 192
APPLICATION OF A THERAPEUTIC SUBSTANCE TO A
TISSUE LOCATION USING AN EXPANDABLE MEDICAL
DEVICE 192
MULTI-STABLE VALVES FOR MEDICAL APPLICATIONS
AND METHODS FOR USE THEREOF .......... 193
METHOD AND APPARATUS FOR DELIVERING COMBINED
ELECTRICAL AND DRUG THERAPIES ....... 193
HEPARIN PRODRUGS AND DRUG DELIVERY STENTS
FORMED THEREFROM ... 194
NANOPARTICLE ASSEMBLED HOLLOW SPHERES ....... 194
METHOD OF STENT MOUNTING TO FORM A BALLOON
CATHETER HAVING IMPROVED RETENTION OF A
DRUG DELIVERY STENT 195
STENT HAVING AN ULTRASONIC EMITTER . 195
DRUG-ELUTING INTRAVASCULAR PROSTHESES AND
METHODS OF USE .......... 196
IMPLANTABLE DRUG DELIVERY DEVICE AND USE
THEREOF 196
INTRA-AORTIC RENAL DELIVERY CATHETER . 197
SYSTEM AND METHOD FOR DRUG DELIVERY AND
MICROFLUIDIC APPLICATIONS USING
MICRONEEDLES 197
ENCAPSULATED INORGANIC ANTIMICROBIAL ADDITIVE
FOR CONTROLLED RELEASE ......... 198
POLYMER NANOTECHNOLOGY .......... 198
CHAPTER EIGHTEEN: INDUSTRY STRUCTURE AND COMPANY
PROFILES .... 199
OVERVIEW .......... 199
REVENUES AND PROFITABILITY 199
COMPANY PROFILES ........ 200
ACRYMED, INC. ........ 200
Acrymed, Inc. (Continued) 201
AFFINERGY, INC. ..... 202
AGION TECHNOLOGIES, INC. . 202
ALEXZA PHARMACEUTICALS . 203
ALLIED MINDS/BIOTECTIX 204
ANGIOTECH PHARMACEUTICALS, INC. ......... 204
ARROW INTERNATIONAL ... 205
AVITA MEDICAL ...... 206
AXCAN PHARMA, INC. ......... 206
BIND BIOSCIENCES, INC. ... 207
BIOCOAT, INC. .......... 208
BIOCOMPATIBLES UK, LTD. ... 209
BIOHEART, INC. ....... 210
BIOMET, INC. ............ 211
BRONCUS TECHNOLOGIES, INC. ........ 212
CELSION CORPORATION .... 213
CODMAN and SHURTLEFF, INC. 214
COLLAGEN MATRIX, INC. ... 214
COOK MEDICAL, INC. .......... 214
CORDIS CORPORATION ...... 215
COVIDIEN, PLC ........ 215
CYNOSURE, INC. ...... 216
DUSA PHARMACEUTICALS, INC. ........ 216
EDWARDS LIFESCIENCES CORP. ....... 217
ENDOVASC, INC. ...... 217
ETEX CORPORATION ........... 218
EXACTECH, INC. ...... 218
FORTICELL, INC. ..... 219
INFRAREDX . 220
INTEGRA LIFESCIENCES HOLDINGS CORP. . 221
INTERPORE CROSS INTERNATIONAL ............ 221
Interpore Cross International (Continued) 222
ISTA PHARMACEUTICALS .. 223
KENSEY NASH CORPORATION ............ 223
KIADIS PHARMA B.V. ........... 224
LIFECELL CORP. ...... 225
MARTECH MEDICAL PRODUCTS ........ 225
MILLENIUM BIOLOGIX, INC. .. 226
MIRAVANT MEDICAL TECHNOLOGIES .......... 226
MIV THERAPEUTICS INC. ... 227
NOVABONE PRODUCTS, LLC .. 228
NUCRYST PHARMACEUTICALS, INC. 229
OMRIX BIOPHARMACEUTICALS, LTD. ........... 230
ORGANOGENESIS, INC. ....... 231
ORTHOVITA, INC. .... 232
PHARMACYCLICS, INC. ....... 233
PHOTOCURE ASA .... 233
PHOTOBIOTICS ........ 234
QLT, INC. .. 235
SMITH and NEPHEW, PLC ...... 235
SORIN S.P.A .. 236
STRYKER CORP. ....... 236
SURMODICS, INC. .... 236
SYNTHES, INC. ......... 237
SYSTAGENIX WOUND MANAGEMENT ............ 238
TEI BIOSCIENCES, INC. ...... 239
WRIGHT MEDICAL GROUP, INC. ......... 239
W. L. GORE and ASSOCIATES, INC. ......... 240
APPENDIX 1: RECENT FDA APPROVALS OF DEVICES, INCLUDING
COMBINATION DEVICES ....... 241
TABLE 33 MEDICAL DEVICES APPROVED BY THE FDA, 2009 ..... 241
TABLE 34 MEDICAL DEVICES APPROVED BY THE FDA, 2008 ..... 242
TABLE 35 MEDICAL DEVICES APPROVED BY THE FDA, 2007 ..... 243
APPENDIX 2: GLOSSARY OF RELEVANT TERMINOLOGY ... 244

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