Drug Eluting Stents (DES) - Medical Devices Pipeline Assessment, 2017

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 15
2 Introduction 16
2.1 Drug Eluting Stents (DES) Overview 16
3 Products under Development 17
3.1 Drug Eluting Stents (DES) - Pipeline Products by Stage of Development 17
3.2 Drug Eluting Stents (DES) - Pipeline Products by Territory 18
3.3 Drug Eluting Stents (DES) - Pipeline Products by Regulatory Path 19
3.4 Drug Eluting Stents (DES) - Pipeline Products by Estimated Approval Date 20
3.5 Drug Eluting Stents (DES) - Ongoing Clinical Trials 21
4 Drug Eluting Stents (DES) - Pipeline Products under Development by Companies 22
4.1 Drug Eluting Stents (DES) Companies - Pipeline Products by Stage of Development 22
4.2 Drug Eluting Stents (DES) - Pipeline Products by Stage of Development 24
5 Drug Eluting Stents (DES) Companies and Product Overview 27
5.1 Aachen Resonance GmbH Company Overview 27
5.1.1 Aachen Resonance GmbH Pipeline Products & Ongoing Clinical Trials Overview 27
5.2 Abbott Vascular Inc Company Overview 28
5.2.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 28
5.3 Adcomp Technologies Inc. Company Overview 34
5.3.1 Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.4 Aeon Bioscience Company Overview 35
5.4.1 Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 35
5.5 AlviMedica Medical Technologies Inc. Company Overview 36
5.5.1 AlviMedica Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 36
5.6 B. Braun Melsungen AG Company Overview 41
5.6.1 B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 41
5.7 Biosensors International Group Ltd Company Overview 42
5.7.1 Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 42
5.8 Biotronik SE & Co KG Company Overview 50
5.8.1 Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 50
5.9 Boston Scientific Corp Company Overview 64
5.9.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 64
5.10 Cardionovum GmbH Company Overview 67
5.10.1 Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 67
5.11 CARDIOREV PTE. LTD Company Overview 68
5.11.1 CARDIOREV PTE. LTD Pipeline Products & Ongoing Clinical Trials Overview 68
5.12 Columbia University Company Overview 69
5.12.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 69
5.13 Cordis Corp Company Overview 70
5.13.1 Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 70
5.14 DISA Vascular (Pty) Ltd Company Overview 74
5.14.1 DISA Vascular (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 74
5.15 Divya Laboratories Company Overview 75
5.15.1 Divya Laboratories Pipeline Products & Ongoing Clinical Trials Overview 75
5.16 Elixir Medical Corp Company Overview 76
5.16.1 Elixir Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 76
5.17 Envision Scientific Pvt. Ltd Company Overview 78
5.17.1 Envision Scientific Pvt. Ltd Pipeline Products & Ongoing Clinical Trials Overview 78
5.18 I.B.S. S.p.A. Company Overview 80
5.18.1 I.B.S. S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 80
5.19 InspireMD Inc Company Overview 81
5.19.1 InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 81
5.20 Kaneka Corp Company Overview 82
5.20.1 Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 82
5.21 Lepu Medical Technology (Beijing) Co Ltd Company Overview 83
5.21.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 83
5.22 Liaoning Biomedical Materials R&D Center Co Ltd Company Overview 86
5.22.1 Liaoning Biomedical Materials R&D Center Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 86
5.23 MangoGen Pharma Inc Company Overview 89
5.23.1 MangoGen Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 89
5.24 Medinol Ltd Company Overview 90
5.24.1 Medinol Ltd Pipeline Products & Ongoing Clinical Trials Overview 90
5.25 Medlogics Device Corp (Inactive) Company Overview 95
5.25.1 Medlogics Device Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 95
5.26 Medtronic plc Company Overview 96
5.26.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 96
5.27 Meril Life Sciences Pvt Ltd Company Overview 105
5.27.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 105
5.28 Micell Technologies Inc Company Overview 112
5.28.1 Micell Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 112
5.29 MicroPort Scientific Corp Company Overview 117
5.29.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 117
5.30 Minvasys SAS Company Overview 124
5.30.1 Minvasys SAS Pipeline Products & Ongoing Clinical Trials Overview 124
5.31 MIV Therapeutics Inc Company Overview 125
5.31.1 MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 125
5.32 Northwestern University Company Overview 129
5.32.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 129
5.33 NuVascular Technologies Inc Company Overview 130
5.33.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 130
5.34 OrbusNeich Company Overview 131
5.34.1 OrbusNeich Pipeline Products & Ongoing Clinical Trials Overview 131
5.35 Relisys Medical Devices Ltd Company Overview 136
5.35.1 Relisys Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 136
5.36 REVA Medical Inc Company Overview 137
5.36.1 REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 137
5.37 Rontis AG Company Overview 139
5.37.1 Rontis AG Pipeline Products & Ongoing Clinical Trials Overview 139
5.38 Sino Medical Sciences Technology Inc Company Overview 140
5.38.1 Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 140
5.39 Stentys SA Company Overview 146
5.39.1 Stentys SA Pipeline Products & Ongoing Clinical Trials Overview 146
5.40 Svelte Medical Systems Inc Company Overview 147
5.40.1 Svelte Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 147
5.41 Terumo Corp Company Overview 151
5.41.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 151
5.42 TissueGen Inc Company Overview 154
5.42.1 TissueGen Inc Pipeline Products & Ongoing Clinical Trials Overview 154
5.43 University of Alabama at Birmingham Company Overview 155
5.43.1 University of Alabama at Birmingham Pipeline Products & Ongoing Clinical Trials Overview 155
5.44 University of Florida Company Overview 156
5.44.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 156
5.45 University of Strathclyde Company Overview 157
5.45.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 157
5.46 Vascular Concepts Ltd Company Overview 159
5.46.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 159
5.47 VasoTech Inc. Company Overview 162
5.47.1 VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 162
5.48 Zorion Medical Company Overview 164
5.48.1 Zorion Medical Pipeline Products & Ongoing Clinical Trials Overview 164
6 Drug Eluting Stents (DES)- Recent Developments 165
6.1 Sep 01, 2017: REVA Appoints Brandi Roberts as Chief Financial Officer and Company Secretary 165
6.2 Aug 29, 2017: Abbott Issues New Updates for Implanted Cardiac Devices 165
6.3 Aug 28, 2017: ESC Congress 2017: BIOTRONIK's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial 166
6.4 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 167
6.5 Aug 14, 2017: Medtronic Announces Randomized Global Resolute Onyx(TM) DES One-Month Dual Antiplatelet Therapy Study to Address Critical Unanswered Question in Interventional Cardiology 169
6.6 Aug 14, 2017: MicroPort Broadcasts a High-risk Live Case of Firehawk in SOLACI 2017 171
6.7 Aug 14, 2017: Firehawk Displayed in 14th ICSM Annual Conference 171
6.8 Aug 14, 2017: Firehawk Rapamycin Target Eluting Coronary Stent System Obtain Regulatory Approval in Malaysia 172
6.9 Aug 11, 2017: MPSC Issues Positive Profit Alert for 2017 1H Net Profit Expected to Increase 261% 172
6.10 Aug 10, 2017: REVA Medical: Half-Yearly Report 172
6.11 Aug 08, 2017: Inspire Reports Double Digit Sequential and Year-Over-Year Revenue Growth for the Second Quarter of 2017 174
6.12 Aug 08, 2017: InspireMD Reports Double Digit Sequential and Year-Over-Year Revenue Growth for the Second Quarter of 2017 175
6.13 Jul 31, 2017: REVA Medical: Quarter Ended 30 June 2017 177
6.14 Jul 31, 2017: Dr. Joachim Schulz joins the Management Board of B. Braun Melsungen 177
6.15 Jul 28, 2017: Indonesian Minister of Health Launches New German Pharmaceutical Factory in Karawang 178
6.16 Jul 27, 2017: STENTYS Completes Enrollment in the Study Assessing the Safety and Efficacy of Xposition S in Left Main Artery Lesions 178
6.17 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 179
6.18 Jul 24, 2017: MicroPort Attends EUROPACE-CARDIOSTIM 2017 181
6.19 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 181
6.20 Jul 13, 2017: REVA Medical Announces Organizational Changes 183
6.21 Jul 12, 2017: STENTYS: Revenues Of €1.7 Million in the Second Quarter Of 2017 184
6.22 Jul 10, 2017: Updated meta-analysis to compare the efficacy and safety of S-DAPT versus L-DAPT strategies 185
6.23 Jul 07, 2017: Firefighter PTCA Balloon Dilatation Catheter Gains Regulatory Approval in Brazil 186
6.24 Jul 07, 2017: MicroPort Attends China and CEEC Health Economy Conference and Exhibition 186
6.25 Jul 07, 2017: MPSC New COO Glendy Wang on Board 187
6.26 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 187
6.27 Jun 19, 2017: MicroPort Attends OCC 2017 189
6.28 Jun 09, 2017: REVA Medical: Changes to Board of Directors 190
6.29 Jun 08, 2017: B. Braun is participating in the third edition of the High-Tech Founders Fund 190
6.30 Jun 02, 2017: First Patient Enrolled for Firehawk Malaysian TARGET MR Clinical Trial 191
6.31 Jun 02, 2017: InspireMD Announces Appointment of Paul Stuka as Chairman of the Board 191
6.32 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 192
6.33 May 23, 2017: MicroPort Firehawk Shows Promising Three-month OCT Results from TARGET All Comers Trial 195
6.34 May 23, 2017: MicroPort Broadcasted Two Complex Operations with Firehawk in EuroPCR 2017 196
6.35 May 23, 2017: MicroPort Releases the Latest Clinical Data of TARGET Series Studies 196
6.36 May 23, 2017: MicroPort Broadcasts a Live Case of Firesorb in EuroPCR 197
6.37 May 18, 2017: Medtronic RESOLUTE ONYX 2.0 mm Clinical Study Meets Primary Endpoint In Extra-Small Vessels At One-Year 198
6.38 May 16, 2017: EuroPCR 2017: Magmaris Resorbable Scaffold Shows Safety and Stability in 24-Month Data; No Instances of Scaffold Thrombosis 199
6.39 May 16, 2017: First Pennsylvania Patient Treated in Landmark Heart Artery Stent Trial 199
6.40 May 16, 2017: Micell Technologies Announces MiStent Achieved Primary Endpoint in All-Comers Randomized Clinical Trial Versus Xience 200
6.41 May 16, 2017: Svelte Medical Systems Announces Sustained Outstanding Outcomes in Clinical Studies 201
6.42 May 10, 2017: Boston Scientific To Present Data on SYNERGY Stent at EuroPCR 2017 202
6.43 May 01, 2017: Medtronic Launches Resolute Onyx Drug-Eluting Stent in United States Following FDA Approval Becoming First DES Available in 4.5 mm and 5 mm Sizes 202
6.44 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 203
6.45 Apr 24, 2017: STENTYS Reports a 22% Increase in Revenues in the First Quarter of 2017 204
6.46 Apr 21, 2017: MicroPort Signs MOU with Ministry of Health of Malaysia Initiating Firehawk TARGET MALAYSIA REGISTRY 205
6.47 Apr 21, 2017: MicroPort Attends CIT 2017 and Releases One-year Clinical and Angiographic Results of Firesorb FUTURE I Trial 206
6.48 Apr 19, 2017: Abbott Reports First-Quarter 2017 Results 208
6.49 Apr 12, 2017: Change in the B. Braun Management Board and the Aesculap Management Board 210
6.50 Apr 10, 2017: Firehawk Obtains Regulatory Approval in Colombia 210
6.51 Apr 04, 2017: First patient enrolled in major new study investigating abbreviated DAPT post-stent in high bleeding risk patients 211
6.52 Apr 03, 2017: STENTYS is Strengthening Its Board by Co-Opting Two New Independent Members 212
6.53 Mar 31, 2017: B. Braun continues its sales and earnings growth 212
6.54 Mar 30, 2017: 1,000 Magmaris Implantations Reveal High Deployment Success and Physician Satisfaction 214
6.55 Mar 30, 2017: MPSC Announces 2016 Annual Results 215
6.56 Mar 22, 2017: Biosensors Announces Enrollment of the First American Patient in the New US Pivotal Biofreedom Trial - "LEADERS FREE II" 216
6.57 Mar 20, 2017: Japan Circulation Society 2017: Orsiro Drug-Eluting Coronary Stent Convinces in BIOFLOW-IV Study 217
6.58 Mar 20, 2017: MPSC Launches Firehawk in Press Conference and INDIA LIVE 218
6.59 Mar 20, 2017: MicroPort Hosts the Investigator Meeting for Firesorb Pivotal Clinical Study - FUTURE II Trial 218
6.60 Mar 06, 2017: MicroPort Attends CADECI and Completes First Firehawk Implantation in Mexico 219
6.61 Mar 06, 2017: Firehawk Displayed in 2017 Pakistan Live 220
6.62 Mar 06, 2017: Firehawk Receives Regulatory Approval in Mexico 220
6.63 Mar 06, 2017: MicroPort Holds Two Coronary Artery CTO Workshops in Malaysia 221
6.64 Feb 25, 2017: First Implantation of Firehawk in India Completed 221
6.65 Feb 22, 2017: Change in the B. Braun Management Board 222
6.66 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 222
6.67 Feb 16, 2017: Medinol Announces Appointment Of Harvey J. Berger, M.D., As Executive Chairman Of Medinol US 225
6.68 Feb 16, 2017: InspireMD Provides Year End Business Update and Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2016 225
6.69 Feb 15, 2017: Biosensors Announces Enrollment of First Patient in New US Pivotal BioFreedom Trial - "LEADERS FREE II" 227
6.70 Feb 14, 2017: Firehawk Receives Regulatory Approval in South Korea 227
6.71 Feb 09, 2017: Terumo Announces Change of Executive Officers 228
6.72 Feb 08, 2017: Firesorb Displayed in Taiwan Transcatheter Therapeutics 2017 229
6.73 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 229
6.74 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 230
6.75 Jan 31, 2017: REVA Medical: Quarter Ended 31 December 2016 231
6.76 Jan 31, 2017: Terumo Opens a Branch in Yangon 232
6.77 Jan 16, 2017: MicroPort Attends 19th Annual Meeting of CHEA 233
6.78 Jan 12, 2017: First Indian Rate Contract Kicks Off in 2017 233
6.79 Jan 12, 2017: STENTYS: 2016 Annual Revenues up 20% at €7.3 Million 234
6.80 Dec 21, 2016: Medinol announces excellent clinical results for EluNIR, a novel Drug Eluting Stent 235
6.81 Dec 19, 2016: Opto Circuits and its subsidiaries receives orders worth Rs. 910 millions from Philips Health Care 236
6.82 Dec 12, 2016: Terumo Formulates 5-Year Mid- to Long-term Growth Strategy 236
6.83 Nov 28, 2016: Micell Technologies Announces First Patient Enrolled In Landmark Registration Trial Of MiStent In Japan 236
6.84 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 237
6.85 Nov 21, 2016: OrbusNeich Introduces a New Generation COMBO Plus Dual Therapy Stent for Active Healing 240
6.86 Nov 18, 2016: MicroPort's Firesorb Stars in TCT 2016 241
6.87 Nov 18, 2016: MicroPort's Firehawk Stars in TCT 2016 242
6.88 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 242
6.89 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 243
6.90 Nov 14, 2016: InspireMD Reports Financial Results for the Third Quarter Ended September 30, 2016 243
6.91 Nov 07, 2016: Medinol receives approval from the Japanese PMDA to begin clinical study on novel DES 246
6.92 Nov 07, 2016: ARIAD Reports Third Quarter 2016 Financial Results 246
6.93 Nov 02, 2016: Hybrid Sirolimus-Eluting Stents with Biodegradable Polymer did not Improve Angiographic Outcomes Compared to Everolimus-Eluting Stents with Durable Polymer in Treatment of CTOs 249
6.94 Nov 02, 2016: Imaging Study Shows High Rate of Strut Coverage and Low Rates of Neoatherosclerosis with Thin Strut Bioresorbable Polymer-Based and Durable Polymer-Based Drug-Eluting Stents 250
6.95 Nov 01, 2016: TCT 2016: Physicians Share Positive Experiences with Magmaris Resorbable Scaffold at Symposium 251
6.96 Oct 31, 2016: First Clinical Data of Medtronic Drug-Filled Stent Show Positive Outcomes 252
6.97 Oct 31, 2016: TCT 2016: Orsiro Drug-Eluting Stent Proves Non-Inferiority to Resolute Integrity and Synergy Stents 253
6.98 Oct 31, 2016: Positive Five-Year Clinical Data from Micell Technologies' MiStent Presented at TCT 2016 253
6.99 Oct 31, 2016: Svelte Medical Systems Announces Start of DIRECT III Post-Market Registry Study 255
6.100 Oct 31, 2016: Trial Results Suggest that Drug-Eluting Stents are Acceptable Alternative to Open Heart Surgery for Select Patients with Left Main Coronary Artery Disease 255
6.101 Oct 30, 2016: Independent Study Finds Biodegradable Polymer Stents Provide No Clinical Benefit Over Resolute Integrity DES 256
6.102 Oct 30, 2016: Very Thin-Strut Biodegradable Polymer Everolimus-Eluting and Sirolimus-Eluting Stents Shown to be Non-Inferior To Durable Polymer Zotarolimus-Eluting Stents in All-Comers with Coronary Artery Disease 257
6.103 Oct 28, 2016: MicroPort Wins Annual PMO Award of PMI (China) 258
6.104 Oct 28, 2016: REVA Medical: Quarter Ended 30 September 2016 259
6.105 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 260
6.106 Oct 24, 2016: Svelte Medical Systems Announces CE Mark Certification of DIRECT RX 261
6.107 Oct 19, 2016: Firehawk Receives South Korea KGMP Certification 262
6.108 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 262
6.109 Oct 19, 2016: Elixir Medical Announces Schedule of Programs for TCT 2016 265
6.110 Oct 17, 2016: First Firehawk Implantation in Pakistan Completed 267
6.111 Oct 17, 2016: MicroPort Concludes Enrollment In Randomized, Multicenter, European Study Of Firehawk Coronary Stent System 267
6.112 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 268
6.113 Sep 29, 2016: BIOTRONIK Begins Manufacturing High-Tech Products in Singapore 269
6.114 Sep 15, 2016: STENTYS Reports 2016 First-Half Results 269
6.115 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 271
6.116 Sep 12, 2016: Firehawk Receives Regulatory Approval in Pakistan 272
7 Appendix 273
7.1 Methodology 273
7.2 About GlobalData 276
7.3 Contact Us 276
7.4 Disclaimer 276

1.1 List of Tables
Table 1: Drug Eluting Stents (DES) - Pipeline Products by Stage of Development 17
Table 2: Drug Eluting Stents (DES) - Pipeline Products by Territory 18
Table 3: Drug Eluting Stents (DES) - Pipeline Products by Regulatory Path 19
Table 4: Drug Eluting Stents (DES) - Pipeline Products by Estimated Approval Date 20
Table 5: Drug Eluting Stents (DES) - Ongoing Clinical Trials 21
Table 6: Drug Eluting Stents (DES) Companies - Pipeline Products by Stage of Development 22
Table 7: Drug Eluting Stents (DES) - Pipeline Products by Stage of Development 24
Table 8: Aachen Resonance GmbH Pipeline Products & Ongoing Clinical Trials Overview 27
Table 9: ARtax Coronary Stent - Product Status 27
Table 10: ARtax Coronary Stent - Product Description 27
Table 11: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 28
Table 12: Xience SBA Everolimus Eluting Coronary Stent System - Product Status 28
Table 13: Xience SBA Everolimus Eluting Coronary Stent System - Product Description 28
Table 14: XIENCE Thinman DES - Product Status 29
Table 15: XIENCE Thinman DES - Product Description 29
Table 16: ZoMaxx Drug Eluting Coronary Stent System - Product Status 29
Table 17: ZoMaxx Drug Eluting Coronary Stent System - Product Description 29
Table 18: Abbott Vascular Inc - Ongoing Clinical Trials Overview 30
Table 19: Xience SBA Everolimus Eluting Coronary Stent System - A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients with Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes 31
Table 20: Xience SBA Everolimus Eluting Coronary Stent System - A Prospective Multicenter Randomized Post Market All-comer Trial to Assess the Safety and Effectiveness of the Supraflex Sirolimus-eluting Coronary Stent System for the Treatment of Atherosclerotic Lesion(s) 31
Table 21: Xience SBA Everolimus Eluting Coronary Stent System - Short and Optimal Duration of Dual Antiplatelet Therapy-2 Study 31
Table 22: Xience SBA Everolimus Eluting Coronary Stent System - XIENCE Short DAPT Study 32
Table 23: XIENCE Thinman DES - XIENCE Short DAPT Study 33
Table 24: Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 25: Dual Drug Eluting Stent - Product Status 34
Table 26: Dual Drug Eluting Stent - Product Description 34
Table 27: Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 35
Table 28: Drug Eluting Stent - Product Status 35
Table 29: Drug Eluting Stent - Product Description 35
Table 30: AlviMedica Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 36
Table 31: Cre8 DES - Product Status 36
Table 32: Cre8 DES - Product Description 36
Table 33: DES - Coracto - Product Status 37
Table 34: DES - Coracto - Product Description 37
Table 35: Janus Flex - Product Status 37
Table 36: Janus Flex - Product Description 38
Table 37: Optima Jet - Product Status 38
Table 38: Optima Jet - Product Description 38
Table 39: AlviMedica Medical Technologies Inc. - Ongoing Clinical Trials Overview 39
Table 40: Cre8 DES - A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent Versus the RESOLUTE Zotarolimus-eluting Stent in the Treatment of Patients with De Novo Coronary Artery Lesions 40
Table 41: Cre8 DES - A Prospective, Multi-center, Single-arm Observational Registry Trial Evaluating the Safety and Efficacy of CRE8 Sirolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions 40
Table 42: Cre8 DES - A Prospective, Single Center, Open Label, Randomized Controlled, Two Arm Study Evaluating Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent Resolute Integrity Compared to the Polymer Free Amphilimus Eluting Stent Cre8 40
Table 43: B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 41
Table 44: Coroflex DEBlue - Product Status 41
Table 45: Coroflex DEBlue - Product Description 41
Table 46: Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 42
Table 47: BioFreedom Drug Coated Stent - Product Status 42
Table 48: BioFreedom Drug Coated Stent - Product Description 42
Table 49: Excel II DES - Product Status 43
Table 50: Excel II DES - Product Description 43
Table 51: Sparrow Drug Eluting Stent System - Product Status 43
Table 52: Sparrow Drug Eluting Stent System - Product Description 44
Table 53: Biosensors International Group Ltd - Ongoing Clinical Trials Overview 45
Table 54: BioFreedom Drug Coated Stent - A Prospective Study of the BioFreedom Biolimus A9 Drug Coated Stent in Patients at High Risk for Bleeding 46
Table 55: BioFreedom Drug Coated Stent - A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation 46
Table 56: BioFreedom Drug Coated Stent - A Randomized Multicenter Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions 46
Table 57: BioFreedom Drug Coated Stent - A Study Evaluating the Safety and Efficacy of the BioFreedom Biolimus A9 Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding 47
Table 58: BioFreedom Drug Coated Stent - Evaluation of Effectiveness and Safety of BioFreedom Stent in Routine Clinical Practice: A Multicenter, Prospective Observational Study 47
Table 59: BioFreedom Drug Coated Stent - Prospective Multi center Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients with Coronary Artery Disease (Biofreedom Registry) 47
Table 60: BioFreedom Drug Coated Stent - Randomized Comparison of a Polymer-free Biolimus-eluting BioFreedom Stent with a Biodegradable-polymer Sirolimus-eluting Orsiro Stent in Patients Treated with Percutaneous Coronary Intervention 48
Table 61: BioFreedom Drug Coated Stent - Randomized Comparison of Vascular Healing of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent with a Biodegradable-polymer Sirolimus-eluting ORSIRO Stent in Patients with ST-segment Elevation Myocardial Infarction 48
Table 62: BioFreedom Drug Coated Stent - To Collect Additional Safety and Effectiveness Data for the Biosensors BioFreedom BA9 Drug Coated Coronary Stent in Patients with Native, de Novo Coronary Artery Disease 48
Table 63: Excel II DES - A Prospective Multicenter Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II Sirolimus Eluting Stent vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients with de Novo Coronary Artery Lesions (CREDIT II Trial) 49
Table 64: Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 50
Table 65: Orsiro Hybrid Drug Eluting Stent - Product Status 50
Table 66: Orsiro Hybrid Drug Eluting Stent - Product Description 51
Table 67: ProGenic Pimecrolimus-eluting Coronary Stent System - Product Status 51
Table 68: ProGenic Pimecrolimus-eluting Coronary Stent System - Product Description 51
Table 69: Biotronik SE & Co KG - Ongoing Clinical Trials Overview 52
Table 70: Orsiro Hybrid Drug Eluting Stent - A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-eluting Stent with a Durable Polymer Everolimus-eluting Stent for Patients with Acute ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention 55
Table 71: Orsiro Hybrid Drug Eluting Stent - Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial with Stent Evaluation in All-comers IV (TWENTE IV) 55
Table 72: Orsiro Hybrid Drug Eluting Stent - BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment of Subjects with up to Three De Novo or Restenotic Coronary Artery Lesions - V 55
Table 73: Orsiro Hybrid Drug Eluting Stent - Biotronik - Safety and Performance Registry for an All-comers Diabetic Patient Population with the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Asia 56
Table 74: Orsiro Hybrid Drug Eluting Stent - Biotronik - Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Belgium 56
Table 75: Orsiro Hybrid Drug Eluting Stent - BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III French Satellite 56
Table 76: Orsiro Hybrid Drug Eluting Stent - BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice - III Hungary 57
Table 77: Orsiro Hybrid Drug Eluting Stent - BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice - III United Kingdom Satellite 57
Table 78: Orsiro Hybrid Drug Eluting Stent - Biotronik- Safety and Performance Registry for an all Comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice III- Eladis 57
Table 79: Orsiro Hybrid Drug Eluting Stent - Biotronik-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects with up to Two de Novo Coronary Artery Lesions - IV 58
Table 80: Orsiro Hybrid Drug Eluting Stent - BIOTRONIK-Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects with de Novo Coronary Artery Lesions-VI 58
Table 81: Orsiro Hybrid Drug Eluting Stent - BIOTRONIK-Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects with Single de Novo Coronary Artery Lesions - II 58
Table 82: Orsiro Hybrid Drug Eluting Stent - Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population: Randomized Multicenter Trial in an All Comers Population Treated within the Netherlands 3: TWENTE 3 59
Table 83: Orsiro Hybrid Drug Eluting Stent - Comparison of Biomatrix and Orsiro Drug Eluting Stent in Angiographic Result in Patients with All-comer Patients with Coronary Artery Disease : A Multicenter, Randomized, Open Label Study (BIODEGRADE Study) 59
Table 84: Orsiro Hybrid Drug Eluting Stent - Evaluation of Effectiveness and Safety of Orsiro in Routine Clinical Practice: A Multicenter, Prospective Observational Study 59
Table 85: Orsiro Hybrid Drug Eluting Stent - Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 60
Table 86: Orsiro Hybrid Drug Eluting Stent - Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention with Next Generation Drug-eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial 60
Table 87: Orsiro Hybrid Drug Eluting Stent - Magnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients with Acute ST Segment Elevation Myocardial Infarction 60
Table 88: Orsiro Hybrid Drug Eluting Stent - Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation: GUIDE-DES Trial 61
Table 89: Orsiro Hybrid Drug Eluting Stent - Randomized Clinical Comparison of a Combined Sirolimus Eluting and Endothelial Progenitor Cell COMBO Stent with a Sirolimus-eluting OSIRO Stent in Patients Treated with Percutaneous Coronary Intervention - The SORT-OUT X Study 61
Table 90: Orsiro Hybrid Drug Eluting Stent - Randomized Comparison of a Polymer-free Biolimus-eluting BioFreedom Stent with a Biodegradable-polymer Sirolimus-eluting Orsiro Stent in Patients Treated with Percutaneous Coronary Intervention 61
Table 91: Orsiro Hybrid Drug Eluting Stent - Randomized Comparison of Vascular Healing of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent with a Biodegradable-polymer Sirolimus-eluting ORSIRO Stent in Patients with ST-segment Elevation Myocardial Infarction 62
Table 92: Orsiro Hybrid Drug Eluting Stent - Safety and Performance Registry for an All Comers Patient Population with the Limus Eluting Orsiro Stent Within Daily Clinical Practice III -Italy 62
Table 93: Orsiro Hybrid Drug Eluting Stent - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Canada 62
Table 94: Orsiro Hybrid Drug Eluting Stent - Safety and Performance Registry for an All-comers Patient Population with the Limus Eluting Orsiro Stent System within Daily Clinical Practice - III Russia 63
Table 95: Orsiro Hybrid Drug Eluting Stent - The Comparison of Strategies to PREPARE Severely CalCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions 63
Table 96: B