Coronary - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 10

1.2 List of Figures 23

2 Introduction 24

2.1 Coronary Stents Overview 24

3 Products under Development 25

3.1 Coronary Stents-Pipeline Products by Stage of Development 25

3.2 Coronary Stents-Pipeline Products by Segment 26

3.3 Coronary Stents-Pipeline Products by Territory 27

3.4 Coronary Stents-Pipeline Products by Regulatory Path 29

3.5 Coronary Stents-Pipeline Products by Estimated Approval Date 30

3.6 Coronary Stents-Ongoing Clinical Trials 31

4 Coronary Stents-Pipeline Products under Development by Companies 32

4.1 Coronary Stents Companies-Pipeline Products by Stage of Development 32

4.2 Coronary Stents-Pipeline Products by Stage of Development 36

5 Coronary Stents Companies and Product Overview 41

5.1 480 Biomedical Inc Company Overview 41

5.2 Aachen Resonance GmbH Company Overview 42

5.3 Abbott Vascular Inc Company Overview 43

5.4 Adcomp Technologies Inc. Company Overview 50

5.5 Advanced Bifurcation Systems Inc Company Overview 51

5.6 Aeon Bioscience Company Overview 53

5.7 AlviMedica Medical Technologies Inc. Company Overview 54

5.8 Amaranth Medical Inc Company Overview 61

5.9 Arterius Ltd Company Overview 69

5.10 Atrium Medical Corp Company Overview 70

5.11 Axordia Ltd (Inactive) Company Overview 71

5.12 B. Braun Melsungen AG Company Overview 72

5.13 Bionext Biotech Products Ltd. Company Overview 73

5.14 Biosensors International Group Ltd Company Overview 74

5.15 Biosten, LLC Company Overview 82

5.16 Biotronik AG Company Overview 83

5.17 Biotronik SE & Co KG Company Overview 102

5.18 Boston Scientific Corp Company Overview 105

5.19 Cardionovum GmbH Company Overview 110

5.20 Cardiorev Pte Ltd (Inactive) Company Overview 113

5.21 Columbia University Company Overview 114

5.22 Contego Medical, LLC Company Overview 115

5.23 Cordis Corp Company Overview 116

5.24 Cytograft Tissue Engineering Inc (Inactive) Company Overview 120

5.25 DISA Vascular (Pty) Ltd Company Overview 121

5.26 Elixir Medical Corp Company Overview 122

5.27 Envision Scientific Pvt. Ltd Company Overview 124

5.28 HangZhou HuaAn Biotechnology Co., Ltd. Company Overview 126

5.29 I.B.S. S.p.A. Company Overview 127

5.30 Icon Interventional Systems, Inc. Company Overview 128

5.31 ID Nest Medical SAS Company Overview 129

5.32 InspireMD Inc Company Overview 130

5.33 Japan Stent Technology Co., Ltd. Company Overview 134

5.34 Kaneka Corp Company Overview 135

5.35 Kyoto Medical Planning Co Ltd Company Overview 136

5.36 Lepu Medical Technology (Beijing) Co Ltd Company Overview 137

5.37 Liaoning Biomedical Materials R&D Center Co Ltd Company Overview 140

5.38 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 143

5.39 MangoGen Pharma Inc Company Overview 146

5.40 Manli Cardiology Ltd Company Overview 147

5.41 Medinol Ltd Company Overview 148

5.42 Medlogics Device Corp (Inactive) Company Overview 154

5.43 Medtronic plc Company Overview 155

5.44 Meril Life Sciences Pvt Ltd Company Overview 168

5.45 Miami Cardiovascular Innovations Company Overview 177

5.46 Micell Technologies Inc Company Overview 178

5.47 Michigan Technological University Company Overview 183

5.48 MicroPort Scientific Corp Company Overview 184

5.49 Minvasys SAS Company Overview 190

5.50 MIV Therapeutics Inc Company Overview 191

5.51 NanoCoeur, Inc. Company Overview 196

5.52 Nanova, Inc Company Overview 197

5.53 National University of Ireland Galway Company Overview 198

5.54 Nesstent Ltd. Company Overview 199

5.55 Nexeon MedSystems Inc Company Overview 200

5.56 North Carolina State University Company Overview 201

5.57 Northwestern University Company Overview 202

5.58 NuVascular Technologies Inc Company Overview 203

5.59 OrbusNeich Company Overview 204

5.60 Palmaz Scientific Inc (Inactive) Company Overview 210

5.61 Pediastent LLC Company Overview 211

5.62 QualiMed Innovative Medizinprodukte GmbH Company Overview 212

5.63 Qvanteq AG Company Overview 213

5.64 Relisys Medical Devices Ltd Company Overview 214

5.65 REVA Medical Inc Company Overview 215

5.66 Rontis AG Company Overview 222

5.67 S3V Vascular Technologies Company Overview 223

5.68 Sahajanand Medical Technologies Pvt Ltd Company Overview 224

5.69 Shanghai MicroPort Medical Group Co Ltd Company Overview 225

5.70 Sino Medical Sciences Technology Inc Company Overview 228

5.71 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 234

5.72 Stentys SA Company Overview 236

5.73 Svelte Medical Systems Inc Company Overview 237

5.74 Tepha Inc Company Overview 242

5.75 Terumo Corp Company Overview 243

5.76 TissueGen Inc Company Overview 246

5.77 TrendyMED Inc. Company Overview 247

5.78 University of Alabama at Birmingham Company Overview 248

5.79 University of Colorado Company Overview 249

5.80 University of Florida Company Overview 250

5.81 University of Gottingen Company Overview 251

5.82 University of Michigan Company Overview 252

5.83 University of Strathclyde Company Overview 253

5.84 University of Utah Company Overview 255

5.85 Vascular Concepts Ltd Company Overview 256

5.86 VasoTech Inc. Company Overview 261

5.87 Vornia Biomaterials Ltd Company Overview 263

5.88 Xenogenics Corporation Company Overview 264

6 Coronary Stents- Recent Developments 267

6.1 May 24, 2018: Reva Symposium Showcases Clinical Data 267

6.2 May 24, 2018: Independent Stent Imaging Study Shows Excellent Healing Profile with Resolute Onyx DES in Complex Patients with Coronary Artery Disease 267

6.3 May 24, 2018: Terumo to Launch the Ultimaster Tansei Drug Eluting Stent in Europe 269

6.4 May 24, 2018: New Data Presented at EuroPCR Confirms Orsiro's Position as a Leading DES 269

6.5 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 270

6.6 May 23, 2018: Fantom's Positive Two-Year Results Show Sustained Safety and Efficacy 272

6.7 May 23, 2018: Newest Generation of Leading Heart Stent is Now Approved in the U.S. for People with Coronary Artery Disease 273

6.8 May 23, 2018: CeloNova Announces Positive Clinical Results of eCOBRA Study at EuroPCR 2018 274

6.9 May 23, 2018: Positive Two-Year Data from MiStent DESSOLVE III Trial Presented at EuroPCR-Excellent Safety And Low Target Lesion Revascularization (TLR) Rates Persist 274

6.10 May 23, 2018: Amaranth Presented Interim Nine-Month Follow-up MAGNITUDE (98 micron) and Two-Year Follow-up APTITUDE (115 micron) Data at EuroPCR Symposium 276

6.11 May 23, 2018: Fantom's Positive Two-Year Results Show Sustained Safety and Efficacy 277

6.12 May 23, 2018: MicroPort's Firehawk Drug Eluting Stent Achieves Primary Endpoint and Shows Very Promising Results From TARGET All-Comers Clinical Trial 278

6.13 May 23, 2018: BIOTRONIK Announces Further Investment into Magmaris, Its Unique Resorbable Magnesium Scaffold Program 279

6.14 May 22, 2018: PCR statement on Chronic Coronary Syndromes 279

6.15 May 17, 2018: Mr. Jonathan Chen Promoted to Chief International Business Officer of MPSC 281

6.16 May 16, 2018: Reva Announces First Implant Of The Fantom Bioresorbable Scaffold In Turkey 281

6.17 May 16, 2018: InspireMD Receives Regulatory Approval for both CGuard EPS and MGuard Prime in Ecuador 282

6.18 May 16, 2018: Medtronic Begins U.S. Study of Drug-Eluting Stents to Evaluate Treatment of Bifurcation Lesions in Patients with Coronary Artery Disease 283

6.19 May 16, 2018: Surmodics Announces Leadership Change and Appointment of Interim CFO 284

6.20 May 15, 2018: Saama Technologies and ICON Commercialization and Outcomes Partner to Unlock The Value of Real World Evidence 284

6.21 May 15, 2018: Asahi Intecc Group announces financial results and presentation materials for the 3rd Quarter of the fiscal year ending June 2018. 285

6.22 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 285

6.23 May 09, 2018: Reva Medical Announces First Quarter 2018 Financial Results 286

6.24 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 287

6.25 May 02, 2018: Abbott's XIENCE Sierra Heart Stent Receives National Reimbursement in Japan to Treat People with Coronary Artery Disease 287

6.26 May 02, 2018: Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 288

6.27 May 02, 2018: CORRECTING and REPLACING Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance 289

6.28 May 02, 2018: ICON Reports First Quarter 2018 Results 290

7 Appendix 452

7.1 Methodology 452

7.2 About GlobalData 455

7.3 Contact Us 455

7.4 Disclaimer 455

List of Figure

1.2 List of Figures

Figure 1: Coronary Stents-Pipeline Products by Stage of Development 27

Figure 2: Coronary Stents-Pipeline Products by Segment 28

Figure 3: Coronary Stents-Pipeline Products by Territory 29

Figure 4: Coronary Stents-Pipeline Products by Regulatory Path 31

Figure 5: Coronary Stents-Pipeline Products by Estimated Approval Date 32

Figure 6: Coronary Stents-Ongoing Clinical Trials 33

List of Table

1.1 List of Tables

Table 1: Coronary Stents-Pipeline Products by Stage of Development 27

Table 2: Coronary Stents-Pipeline Products by Segment 28

Table 3: Coronary Stents-Pipeline Products by Territory 29

Table 4: Coronary Stents-Pipeline Products by Regulatory Path 31

Table 5: Coronary Stents-Pipeline Products by Estimated Approval Date 32

Table 6: Coronary Stents-Ongoing Clinical Trials 33

Table 7: Coronary Stents Companies-Pipeline Products by Stage of Development 34

Table 8: Coronary Stents-Pipeline Products by Stage of Development 38

Table 9: 480 Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 10: Absorbable Scaffold Stent-Neonatal Aortic Coarctation-Product Status 43

Table 11: Absorbable Scaffold Stent-Neonatal Aortic Coarctation-Product Description 43

Table 12: Aachen Resonance GmbH Pipeline Products & Ongoing Clinical Trials Overview 44

Table 13: ARtax Coronary Stent-Product Status 44

Table 14: ARtax Coronary Stent-Product Description 44

Table 15: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Table 16: Second Generation Bioresorbable Vascular Scaffold-Product Status 45

Table 17: Second Generation Bioresorbable Vascular Scaffold-Product Description 45

Table 18: Xience SBA Everolimus Eluting Coronary Stent System-Product Status 46

Table 19: Xience SBA Everolimus Eluting Coronary Stent System-Product Description 46

Table 20: XIENCE Thin man DES-Product Status 46

Table 21: XIENCE Thin man DES-Product Description 47

Table 22: ZoMaxx Drug Eluting Coronary Stent System-Product Status 47

Table 23: ZoMaxx Drug Eluting Coronary Stent System-Product Description 47

Table 24: Abbott Vascular Inc-Ongoing Clinical Trials Overview 48

Table 25: 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 49

Table 26: 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) 49

Table 27: Xience SBA Everolimus Eluting Coronary Stent System-Polish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI) 49

Table 28: Xience SBA Everolimus Eluting Coronary Stent System-Short and Optimal Duration of Dual Antiplatelet Therapy-2 Study 50

Table 29: Xience SBA Everolimus Eluting Coronary Stent System-XIENCE Short DAPT Study 50

Table 30: XIENCE Thin man DES-XIENCE Short DAPT Study 51

Table 31: Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Table 32: Dual Drug Eluting Stent-Product Status 52

Table 33: Dual Drug Eluting Stent-Product Description 52

Table 34: Advanced Bifurcation Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Table 35: Stenting System-Bare Metal Stent-Product Status 53

Table 36: Stenting System-Bare Metal Stent-Product Description 53

Table 37: Stenting System-Drug Eluting Stent-Product Status 54

Table 38: Stenting System-Drug Eluting Stent-Product Description 54

Table 39: Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 55

Table 40: Drug Eluting Stent-Product Status 55

Table 41: Drug Eluting Stent-Product Description 55

Table 42: AlviMedica Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 56

Table 43: BMS-Avantgarde-Product Status 56

Table 44: BMS-Avantgarde-Product Description 56

Table 45: Cre8 DES-Product Status 57

Table 46: Cre8 DES-Product Description 57

Table 47: DES-Coracto-Product Status 57

Table 48: DES-Coracto-Product Description 58

Table 49: Janus Flex-Product Status 58

Table 50: Janus Flex-Product Description 58

Table 51: Optima Jet-Product Status 59

Table 52: Optima Jet-Product Description 59

Table 53: AlviMedica Medical Technologies Inc.-Ongoing Clinical Trials Overview 60

Table 54: 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 61

Table 55: 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 61

Table 56: 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 61

Table 57: Cre8 DES-Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients 62

Table 58: Cre8 DES-Second-generation Drug-eluting Stents in Diabetes: A Randomized Trial: The SUGAR Trial 62

Table 59: Amaranth Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 63

Table 60: 80-micron MAGNITUDE Bioresorbable Scaffold-Product Status 63

Table 61: 80-micron MAGNITUDE Bioresorbable Scaffold-Product Description 63

Table 62: APTITUDE Sirolimus-Eluting Bioresorbable Scaffold-Product Status 64

Table 63: APTITUDE Sirolimus-Eluting Bioresorbable Scaffold-Product Description 64

Table 64: FORTITUDE Scaffold-Product Status 64

Table 65: FORTITUDE Scaffold-Product Description 65

Table 66: MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold-Product Status 65

Table 67: MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold-Product Description 65

Table 68: Second Generation FORTITUDE Scaffold-Product Status 66

Table 69: Second Generation FORTITUDE Scaffold-Product Description 66

Table 70: Amaranth Medical Inc-Ongoing Clinical Trials Overview 67

Table 71: FORTITUDE Scaffold-Amaranth Endovascular Study of a Drug-eluting Bioresorbable Coronary Scaffold 68

Table 72: FORTITUDE Scaffold-Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds-European Trial 68

Table 73: APTITUDE Sirolimus-Eluting Bioresorbable Scaffold-Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds-Extended Trial II 69

Table 74: MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold-Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds-Extended Trial III 70

Table 75: Arterius Ltd Pipeline Products & Ongoing Clinical Trials Overview 71

Table 76: Arteriosorb Absorbable Drug-Eluting Scaffold-Product Status 71

Table 77: Arteriosorb Absorbable Drug-Eluting Scaffold-Product Description 71

Table 78: Atrium Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 72

Table 79: Next Generation Super Flexible Cobalt Chromium Coronary Stent-Product Status 72

Table 80: Next Generation Super Flexible Cobalt Chromium Coronary Stent-Product Description 72

Table 81: Axordia Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 73

Table 82: Regenerative Stent-Product Status 73

Table 83: Regenerative Stent-Product Description 73

Table 84: B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 74

Table 85: Coroflex DEBlue-Product Status 74

Table 86: Coroflex DEBlue-Product Description 74

Table 87: Bionext Biotech Products Ltd. Pipeline Products & Ongoing Clinical Trials Overview 75

Table 88: Biostent-Product Status 75

Table 89: Biostent-Product Description 75

Table 90: Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 76

Table 91: BioFreedom Drug Coated Stent-Product Status 76

Table 92: BioFreedom Drug Coated Stent-Product Description 76

Table 93: Excel II DES-Product Status 77

Table 94: Excel II DES-Product Description 77

Table 95: Sparrow Drug Eluting Stent System-Product Status 77

Table 96: Sparrow Drug Eluting Stent System-Product Description 77

Table 97: Biosensors International Group Ltd-Ongoing Clinical Trials Overview 78

Table 98: BioFreedom Drug Coated Stent-A Prospective Study of the BioFreedom Biolimus A9 Drug Coated Stent in Patients at High Risk for Bleeding 79

Table 99: 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 79

Table 100: 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 79

Table 101: 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 80

Table 102: BioFreedom Drug Coated Stent-BioFreedom PK Study in Patients with CAD Who Receive the BioFreedom Biolimus A9 Stent 80

Table 103: BioFreedom Drug Coated Stent-Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 80

Table 104: 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) 81

Table 105: 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 81

Table 106: 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 81

Table 107: 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 82

Table 108: 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) 83

Table 109: Biosten, LLC Pipeline Products & Ongoing Clinical Trials Overview 84

Table 110: Biodegradable Endovascular Implant-Product Status 84

Table 111: Biodegradable Endovascular Implant-Product Description 84

Table 112: Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 85

Table 113: Coronary Stent System-Product Status 85

Table 114: Coronary Stent System-Product Description 85

Table 115: Magmaris Bioresorbable Magnesium Scaffold-Product Status 86

Table 116: Magmaris Bioresorbable Magnesium Scaffold-Product Description 86

Table 117: Orsiro Hybrid Drug Eluting Stent-Product Status 86

Table 118: Orsiro Hybrid Drug Eluting Stent-Product Description 87

Table 119: Biotronik AG-Ongoing Clinical Trials Overview 88

Table 120: 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 91

Table 121: 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 91

Table 122: 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) 91

Table 123: 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 92

Table 124: 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 92