1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 14
2 Introduction 15
2.1 Drug Eluting Stents (DES) Overview 15
3 Products under Development 16
3.1 Drug Eluting Stents (DES) - Pipeline Products by Stage of Development 16
3.2 Drug Eluting Stents (DES) - Pipeline Products by Territory 17
3.3 Drug Eluting Stents (DES) - Pipeline Products by Regulatory Path 18
3.4 Drug Eluting Stents (DES) - Pipeline Products by Estimated Approval Date 19
3.5 Drug Eluting Stents (DES) - Ongoing Clinical Trials 20
4 Drug Eluting Stents (DES) - Pipeline Products under Development by Companies 21
4.1 Drug Eluting Stents (DES) Companies - Pipeline Products by Stage of Development 21
4.2 Drug Eluting Stents (DES) - Pipeline Products by Stage of Development 23
5 Drug Eluting Stents (DES) Companies and Product Overview 26
5.1 Aachen Resonance GmbH Company Overview 26
5.2 Abbott Vascular Inc Company Overview 27
5.3 Adcomp Technologies Inc. Company Overview 33
5.4 Advanced Bifurcation Systems Inc Company Overview 34
5.5 Aeon Bioscience Company Overview 35
5.6 AlviMedica Medical Technologies Inc. Company Overview 36
5.7 B. Braun Melsungen AG Company Overview 42
5.8 Biosensors International Group Ltd Company Overview 43
5.9 Biotronik AG Company Overview 51
5.10 Biotronik SE & Co KG Company Overview 66
5.11 Boston Scientific Corp Company Overview 67
5.12 Cardionovum GmbH Company Overview 69
5.13 Cardiorev Pte Ltd (Inactive) Company Overview 72
5.14 Columbia University Company Overview 73
5.15 Cordis Corp Company Overview 74
5.16 DISA Vascular (Pty) Ltd Company Overview 77
5.17 Elixir Medical Corp Company Overview 78
5.18 Envision Scientific Pvt. Ltd Company Overview 80
5.19 I.B.S. S.p.A. Company Overview 82
5.20 InspireMD Inc Company Overview 83
5.21 Kaneka Corp Company Overview 84
5.22 Liaoning Biomedical Materials R&D Center Co Ltd Company Overview 85
5.23 MangoGen Pharma Inc Company Overview 88
5.24 Medinol Ltd Company Overview 89
5.25 Medlogics Device Corp (Inactive) Company Overview 95
5.26 Medtronic plc Company Overview 96
5.27 Meril Life Sciences Pvt Ltd Company Overview 108
5.28 MicroPort Scientific Corp Company Overview 111
5.29 MIV Therapeutics Inc Company Overview 116
5.30 NuVascular Technologies Inc Company Overview 119
5.31 OrbusNeich Company Overview 120
5.32 Relisys Medical Devices Ltd Company Overview 124
5.33 REVA Medical Inc Company Overview 125
5.34 Sino Medical Sciences Technology Inc Company Overview 127
5.35 Stentys SA Company Overview 133
5.36 Svelte Medical Systems Inc Company Overview 134
5.37 Terumo Corp Company Overview 139
5.38 TissueGen Inc Company Overview 142
5.39 University of Strathclyde Company Overview 143
5.40 Vascular Concepts Ltd Company Overview 145
5.41 VasoTech Inc. Company Overview 148
6 Drug Eluting Stents (DES)- Recent Developments 149
6.1 May 24, 2018: Independent Stent Imaging Study Shows Excellent Healing Profile with Resolute Onyx DES in Complex Patients with Coronary Artery Disease 149
6.2 May 24, 2018: Terumo to Launch the Ultimaster Tansei Drug Eluting Stent in Europe 150
6.3 May 24, 2018: New Data Presented at EuroPCR Confirms Orsiro’s Position as a Leading DES 150
6.4 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 151
6.5 May 23, 2018: Newest Generation of Leading Heart Stent is Now Approved in the U.S. for People with Coronary Artery Disease 153
6.6 May 23, 2018: MicroPort's Firehawk Drug Eluting Stent Achieves Primary Endpoint and Shows Very Promising Results From TARGET All-Comers Clinical Trial 154
6.7 May 22, 2018: PCR statement on Chronic Coronary Syndromes 155
6.8 May 17, 2018: Mr. Jonathan Chen Promoted to Chief International Business Officer of MPSC 156
6.9 May 16, 2018: Medtronic Begins U.S. Study of Drug-Eluting Stents to Evaluate Treatment of Bifurcation Lesions in Patients with Coronary Artery Disease 157
6.10 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 158
6.11 May 09, 2018: Reva Medical Announces First Quarter 2018 Financial Results 158
6.12 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 159
6.13 May 02, 2018: Abbott’s XIENCE Sierra Heart Stent Receives National Reimbursement in Japan to Treat People with Coronary Artery Disease 160
6.14 Apr 27, 2018: Abbott India stops importing Xience Alpine stents 160
6.15 Apr 26, 2018: New Clinical Trial Shows Second Generation Drug-Eluting Stents Are Safe And Effective 161
6.16 Apr 25, 2018: Terumo Acquires CE Marking for Ultimaster Tansei Drug Eluting Stent Available in Europe Starting in May 161
6.17 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 162
6.18 Apr 18, 2018: Abbott Reports First-Quarter 2018 Results 164
6.19 Apr 12, 2018: STENTYS: Financial Information for the First Quarter of 2018 166
6.20 Apr 12, 2018: Asahi Intecc To Begin Direct Sales Of Its Coronary Guide Wires 167
6.21 Apr 11, 2018: Abbott Initiates Groundbreaking Study to Assess Superiority of High-Resolution Imaging Versus Standard-of-Care Angiography in Treating Coronary Artery Disease 168
6.22 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 168
6.23 Mar 29, 2018: Firehawk Gains Regulatory Approval in Myanmar 169
6.24 Mar 29, 2018: MicroPort Attends INDIA LIVE 2018 170
6.25 Mar 28, 2018: MicroPort Scientific Announces 2017 Annual Results 170
6.26 Mar 27, 2018: China Interventional Therapeutics 2018: Orsiro Drug-Eluting Stent Reaches Endpoints in BIOFLOW-VI Study 172
6.27 Mar 27, 2018: MicroPort Scientific Announces Year Ended 31 December 2017 Financial Results 173
6.28 Mar 23, 2018: 2017 fiscal year: B. Braun increases sales and earnings, with investments of one billion euros 173
6.29 Mar 19, 2018: Detroit Medical Center First to Use New Stent for Blocked Blood Vessels 175
6.30 Mar 15, 2018: SuperSonic Imagine Provides Equipment for Gastroenterology Units at Five Hospitals in Auvergne, France 176
6.31 Mar 08, 2018: REVA Medical Reports Fourth Quarter and Full Year 2017 Financial Results 176
6.32 Mar 01, 2018: Study finds the best stent for treatment following a heart attack 178
6.33 Feb 13, 2018: Four start-ups chosen for the B. Braun Accelerator Program 180
6.34 Feb 08, 2018: Firehawk Gains Regulatory Approval in Taiwan 181
6.35 Feb 08, 2018: MicroPort Attends the CCC2018 181
6.36 Feb 08, 2018: Terumo Revises the Full-Year Results Forecast for FY 2017 182
6.37 Feb 06, 2018: DMC Heart Hospital is First in Michigan to Use the Narrowest Stent Width Available in the United States to Treat Coronary Disease 182
6.38 Feb 05, 2018: Reva Appoints Stephen Oesterle As Board Of Directors 183
6.39 Feb 01, 2018: REVA Medical: Quarter Ended 31 December 2017 183
6.40 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 185
6.41 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 186
6.42 Jan 29, 2018: Terumo Integrates Two R&D Facilities in Silicon Valley to Accelerate Development of Innovative Medical Devices 187
6.43 Jan 25, 2018: Terumo Announces Change of Directors and Executive Officers 187
6.44 Jan 24, 2018: Abbott Reports Fourth-Quarter 2017 Results 189
6.45 Jan 22, 2018: Orsiro Coronary Drug-Eluting Stent Receives Market Approval in Japan 192
6.46 Jan 11, 2018: Cordis and Medinol Announce First U.S. Commercial Implants of Innovative EluNIR Drug-Eluting Stent 193
6.47 Jan 10, 2018: Svelte Medical Systems Announces First Patient Enrolled in Pivotal OPTIMIZE Study 193
6.48 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 194
6.49 Jan 08, 2018: MicroPort Attends CBS 2017 195
6.50 Jan 08, 2018: STENTYS Reports Revenues for the Fourth Quarter and Full Year 2017 195
6.51 Jan 03, 2018: Tryton Medical Announces New CEO and President 196
6.52 Dec 19, 2017: Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region 196
6.53 Dec 13, 2017: Terumo Constructs a New Building in Yamaguchi, Japan  To Strengthen Production Operations in Interventional Systems 197
6.54 Dec 12, 2017: B. Braun establishes a subsidiary in Zambia 198
6.55 Dec 11, 2017: Percutaneous coronary intervention is a well-justified treatment option also in severe coronary artery disease 198
6.56 Nov 30, 2017: Cordis and Medinol Announce FDA Approval of the Innovative EluNIR Drug-Eluting Stent System 199
6.57 Nov 24, 2017: MicroPort Hosts Firehawk SAFE Study Protocol Symposium 200
6.58 Nov 24, 2017: MicroPort Attends TCT to Display Firehawk and Firesorb 201
6.59 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 202
6.60 Nov 08, 2017: STENTYS announces the pre-commercialization of SERPENTIS, its new latest-generation of active stent 205
6.61 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 205
6.62 Nov 07, 2017: REVA Medical Reports Third Quarter 2017 Financial Results 206
6.63 Nov 02, 2017: TCT 2017: BIOTRONIK's Orsiro Drug-Eluting Stent Shows Low Five-Year Event Rates in BIOFLOW-II RCT and BIOFLOW-III Registry 208
6.64 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 209
6.65 Nov 01, 2017: Late-Breaking REDUCE Trial Data Demonstrate Non-inferiority of 3 vs. 12 Months Dual Antiplatelet Therapy in Acute Coronary Syndrome Patients Treated With OrbusNeich's COMBO Stent 210
6.66 Nov 01, 2017: Independent Study Shows New Data on Shortened DAPT in STEMI Patients with Medtronic Resolute Integrity Drug-Eluting Stent 211
6.67 Oct 31, 2017: Elixir Medical Corporation Unveils Transformational DynamX Stent Featuring Adaptive Segments that Uncage the Stented Artery 212
6.68 Oct 30, 2017: OrbusNeich's COMBO Dual Therapy Stent Demonstrates Non-inferiority vs. the Market Leading XIENCE Everolimus Eluting Stent 213
6.69 Oct 30, 2017: Abbott Introduces Next Generation of Most Widely Used Heart Stent for People with Coronary Artery Disease in Europe 214
6.70 Oct 30, 2017: Cordis Showcases Innovative Coronary TRYTON Side Branch Stent at TCT 2017 214
6.71 Oct 30, 2017: Cordis Showcases EluNIR Drug-Eluting Stent at TCT 2017 215
6.72 Oct 26, 2017: Medinol Receives CE Mark for the EluNIR Ridaforolimus-Eluting Coronary Stent System, and announces first commercial implantations 216
6.73 Oct 26, 2017: Boston Scientific Announces Results For Third Quarter 2017 216
6.74 Oct 23, 2017: Boston Scientific Announces Clinical Trial Data of Promus Stent System at Transcatheter Cardiovascular Therapeutics 2017 218
6.75 Oct 18, 2017: Abbott Reports Third-Quarter 2017 Results 219
6.76 Oct 16, 2017: REVA Announces Commercial Expansion and the First Implant of the Fantom Bioresorbable Scaffold in Switzerland 222
6.77 Oct 12, 2017: STENTYS: Revenues for the Third Quarter of 2017: Continued Growth for the Xposition S Stent 222
6.78 Oct 10, 2017: The First Case of Firehawk in Kazakhstan Completed 222
6.79 Oct 10, 2017: First Case of Firehawk in Tibet Completed 223
6.80 Oct 10, 2017: Terumo Provides Update on Impact from Hurricane Maria 223
6.81 Oct 09, 2017: BIOTRONIK Announces First Enrollments to BIOVITESSE Trial 224
6.82 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 224
6.83 Oct 04, 2017: Boston Scientific Appoints Desiree Ralls-Morrison General Counsel and Corporate Secretary 226
6.84 Oct 02, 2017: STENTYS: 2017 half-year results 226
6.85 Sep 28, 2017: Nexeon MedSystems Begins Trading as NXNN 227
6.86 Sep 26, 2017: MicroVention Celebrates Grand Opening of New Worldwide Innovation Center in Aliso Viejo, California 227
6.87 Sep 22, 2017: Abbott and the Abbott Fund Provide $2 Million in Additional Relief to Help Families Affected by Hurricane Maria and the Earthquake in Central Mexico 228
6.88 Sep 20, 2017: Reva Announces Ray Larkin  Jr. as Chairman of the Board of Directors 229
6.89 Sep 18, 2017: Abbott and the Abbott Fund Expand Support for Hurricane Relief With $1 Million to Help Families Affected by Hurricane Irma 230
6.90 Sep 13, 2017: MicroPort Hosted the Investigator Meeting for Firehawk TARGET CTO Trial in Beijing 230
6.91 Sep 12, 2017: First Round Of Late-Breaking Endovascular Clinical Trial Results Announced At VIVA 17 231
6.92 Sep 11, 2017: MPSC Achieves Substantial Growth in 1H 2017  Net Profit Increases 272.4% YOY 232
6.93 Sep 07, 2017: Abbott Named Industry Leader for Responsible and Sustainable Business for Five Consecutive Years on the Dow Jones Sustainability Index 234
6.94 Sep 01, 2017: REVA Appoints Brandi Roberts as Chief Financial Officer and Company Secretary 235
6.95 Aug 29, 2017: Abbott and the Abbott Fund Donate $1 Million to Support Hurricane Harvey Relief Efforts 235
6.96 Aug 29, 2017: Abbott Issues New Updates for Implanted Cardiac Devices 235
6.97 Aug 28, 2017: ESC Congress 2017: BIOTRONIK's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial 237
6.98 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 237
6.99 Aug 22, 2017: InspireMD Announces Notification of NYSE AMERICAN Listing Deficiency and Expectation to Regain Compliance 240
6.100 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 240
6.101 Aug 14, 2017: MicroPort Broadcasts a High-risk Live Case of Firehawk in SOLACI 2017 241
6.102 Aug 14, 2017: Firehawk Displayed in 14th ICSM Annual Conference 242
6.103 Aug 14, 2017: Firehawk Rapamycin Target Eluting Coronary Stent System Obtain Regulatory Approval in Malaysia 242
6.104 Aug 11, 2017: MPSC Issues Positive Profit Alert for 2017 1H Net Profit Expected to Increase 261% 243
6.105 Aug 10, 2017: REVA Medical: Half-Yearly Report 243
6.106 Aug 08, 2017: Inspire Reports Double Digit Sequential and Year-Over-Year Revenue Growth for the Second Quarter of 2017 245
6.107 Aug 08, 2017: InspireMD Reports Double Digit Sequential and Year-Over-Year Revenue Growth for the Second Quarter of 2017 246
6.108 Jul 31, 2017: REVA Medical: Quarter Ended 30 June 2017 247
6.109 Jul 31, 2017: Dr. Joachim Schulz joins the Management Board of B. Braun Melsungen 248
6.110 Jul 28, 2017: Indonesian Minister of Health Launches New German Pharmaceutical Factory in Karawang 248
6.111 Jul 27, 2017: STENTYS Completes Enrollment in the Study Assessing the Safety and Efficacy of Xposition S in Left Main Artery Lesions 249
6.112 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 250
6.113 Jul 24, 2017: MicroPort Attends EUROPACE-CARDIOSTIM 2017 251
6.114 Jul 20, 2017: Abbott Reports Second-Quarter 2017 Results 252
6.115 Jul 13, 2017: REVA Medical Announces Organizational Changes 254
6.116 Jul 12, 2017: STENTYS: Revenues Of €1.7 Million in the Second Quarter Of 2017 255
6.117 Jul 10, 2017: Updated meta-analysis to compare the efficacy and safety of S-DAPT versus L-DAPT strategies 256
6.118 Jul 07, 2017: Firefighter PTCA Balloon Dilatation Catheter Gains Regulatory Approval in Brazil 256
6.119 Jul 07, 2017: MicroPort Attends China and CEEC Health Economy Conference and Exhibition 257
6.120 Jul 07, 2017: MPSC New COO Glendy Wang on Board 257
6.121 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 258
6.122 Jun 19, 2017: MicroPort Attends OCC 2017 260
6.123 Jun 09, 2017: REVA Medical: Changes to Board of Directors 260
6.124 Jun 08, 2017: B. Braun is participating in the third edition of the High-Tech Founders Fund 261
7 Appendix 262
7.1 Methodology 262
7.2 About GlobalData 265
7.3 Contact Us 265
7.4 Disclaimer 265

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 Thin man DES - Product Status 29
Table 15: XIENCE Thin man 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 - Polish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI) 31
Table 22: Xience SBA Everolimus Eluting Coronary Stent System - Short and Optimal Duration of Dual Antiplatelet Therapy-2 Study 32
Table 23: Xience SBA Everolimus Eluting Coronary Stent System - XIENCE Short DAPT Study 32
Table 24: XIENCE Thin man DES - XIENCE Short DAPT Study 33
Table 25: Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 26: Dual Drug Eluting Stent - Product Status 34
Table 27: Dual Drug Eluting Stent - Product Description 34
Table 28: Advanced Bifurcation Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 35
Table 29: Stenting System - Drug Eluting Stent - Product Status 35
Table 30: Stenting System - Drug Eluting Stent - Product Description 35
Table 31: Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 36
Table 32: Drug Eluting Stent - Product Status 36
Table 33: Drug Eluting Stent - Product Description 36
Table 34: AlviMedica Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 37
Table 35: Cre8 DES - Product Status 37
Table 36: Cre8 DES - Product Description 37
Table 37: DES - Coracto - Product Status 38
Table 38: DES - Coracto - Product Description 38
Table 39: Janus Flex - Product Status 38
Table 40: Janus Flex - Product Description 39
Table 41: Optima Jet - Product Status 39
Table 42: Optima Jet - Product Description 39
Table 43: AlviMedica Medical Technologies Inc. - Ongoing Clinical Trials Overview 40
Table 44: 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 41
Table 45: 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 41
Table 46: 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 41
Table 47: Cre8 DES - Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients 42
Table 48: Cre8 DES - Second-generation Drug-eluting Stents in Diabetes: A Randomized Trial: The SUGAR Trial 42
Table 49: B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 43
Table 50: Coroflex DEBlue - Product Status 43
Table 51: Coroflex DEBlue - Product Description 43
Table 52: Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 44
Table 53: BioFreedom Drug Coated Stent - Product Status 44
Table 54: BioFreedom Drug Coated Stent - Product Description 44
Table 55: Excel II DES - Product Status 45
Table 56: Excel II DES - Product Description 45
Table 57: Biosensors International Group Ltd - Ongoing Clinical Trials Overview 46
Table 58: BioFreedom Drug Coated Stent - A Prospective Study of the BioFreedom Biolimus A9 Drug Coated Stent in Patients at High Risk for Bleeding 47
Table 59: 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 47
Table 60: 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 47
Table 61: 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 48
Table 62: BioFreedom Drug Coated Stent - BioFreedom PK Study in Patients with CAD Who Receive the BioFreedom Biolimus A9 Stent 48
Table 63: BioFreedom Drug Coated Stent - Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 48
Table 64: 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) 49
Table 65: 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 49
Table 66: 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 49
Table 67: 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 50
Table 68: 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) 51
Table 69: Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 52
Table 70: Coronary Stent System - Product Status 52
Table 71: Coronary Stent System - Product Description 52
Table 72: Orsiro Hybrid Drug Eluting Stent - Product Status 53
Table 73: Orsiro Hybrid Drug Eluting Stent - Product Description 53
Table 74: Biotronik AG - Ongoing Clinical Trials Overview 54
Table 75: 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 57
Table 76: Orsiro Hybrid Drug Eluting Stent - A Randomized Comparison of a Sirolimus-eluting Stent with Biodegradable Polymer Versus an Everolimus-eluting Stent with a Durable Polymer for Percutaneous Coronary Revascularization 57
Table 77: 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) 57
Table 78: 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 58
Table 79: 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 58
Table 80: 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 and Vulnerable Inflammation Parameter Registry 58
Table 81: 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 59
Table 82: 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 59
Table 83: 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 59
Table 84: 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 60
Table 85: 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 60
Table 86: 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 60
Table 87: 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 61
Table 88: Orsiro Hybrid Drug Eluting Stent - Evaluation of Effectiveness and Safety of Orsiro in Routine Clinical Practice: A Multicenter, Prospective Observational Study 61
Table 89: Orsiro Hybrid Drug Eluting Stent - Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 61
Table 90: Orsiro Hybrid Drug Eluting Stent - Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of Prasugrel Dose and Polymer Technology in ACS Patients (HOST REDUCE POLYTECH RCT Trial) Comparison of the Efficacy and Safety of Biostable Polymer DES (Promus Premier, Xience Alpine, and Resolute Onyx) with Biodegradable Polymer DES (Biomatrix, Biomatrix Flex, Nobori, Ultimaster, Synergy, and Orsiro) and Conventional Dose Prasugrel Therapy with Reduced Dose Prasugrel Therapy in Acute Coronary Syndrome Patients Treated with Percutaneous Coronary Intervention 62

1.2 List of Figures
Figure 1: Drug Eluting Stents (DES) - Pipeline Products by Stage of Development 17
Figure 2: Drug Eluting Stents (DES) - Pipeline Products by Territory 18
Figure 3: Drug Eluting Stents (DES) - Pipeline Products by Regulatory Path 19
Figure 4: Drug Eluting Stents (DES) - Pipeline Products by Estimated Approval Date 20
Figure 5: Drug Eluting Stents (DES) - Ongoing Clinical Trials 21