Drug Eluting Stents (DES) – Pipeline Products by Stage of Development 14
Drug Eluting Stents (DES) – Pipeline Products by Territory 15
Drug Eluting Stents (DES) – Pipeline Products by Regulatory Path 16
Drug Eluting Stents (DES) – Pipeline Products by Estimated Approval Date 17
Drug Eluting Stents (DES) – Ongoing Clinical Trials 18
Drug Eluting Stents (DES) Companies – Pipeline Products by Stage of Development 19
Drug Eluting Stents (DES) – Pipeline Products by Stage of Development 21
Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 23
Xience Bioprime – Product Status 23
Xience Bioprime – Product Description 23
Xience Max – Product Status 24
Xience Max – Product Description 24
Xience SBA Everolimus Eluting Coronary Stent System – Product Status 24
Xience SBA Everolimus Eluting Coronary Stent System – Product Description 25
XIENCE Thinman DES – Product Status 25
XIENCE Thinman DES – Product Description 25
ZoMaxx Drug Eluting Coronary Stent System – Product Status 26
ZoMaxx Drug Eluting Coronary Stent System – Product Description 26
Abbott Vascular Inc – Ongoing Clinical Trials Overview 27
Xience SBA Everolimus Eluting Coronary Stent System – A Multi-center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries: CRYSTAL Study 28
Xience SBA Everolimus Eluting Coronary Stent System – A Prospective, Multi-center, Single-blinded, Randomized Trial of the Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System in Patients with Coronary Artery Disease: IRONMAN-II 28
Xience SBA Everolimus Eluting Coronary Stent System – Intracoronary Stenting and Restenosis – Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5 28
Adcomp Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 29
Dual Drug Eluting Stent – Product Status 29
Dual Drug Eluting Stent – Product Description 29
Advanced Bifurcation Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 30
ABS Stenting System – Drug Eluting Stent – Product Status 30
ABS Stenting System – Drug Eluting Stent – Product Description 30
Aeon Bioscience Pipeline Products & Ongoing Clinical Trials Overview 31
Drug Eluting Stent – Product Status 31
Drug Eluting Stent – Product Description 31
B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 32
Coroflex DEBlue – Product Status 32
Coroflex DEBlue – Product Description 32
Biosensors International Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 33
BioFreedom Ultra – Product Status 33
BioFreedom Ultra – Product Description 33
Biosensors International Group Ltd – Ongoing Clinical Trials Overview 34
BioFreedom Ultra – A Pilot Study Registry of the BioFreedom BA9 Ultra Drug-Coated Coronary Stent for Patients With ST Elevation Myocardial Infarct (STEMI) Undergoing Percutaneous Coronary Intervention (PCI) 35
BioFreedom Ultra – A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System 35
BioFreedom Ultra – A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System 35
BioFreedom Ultra – A Prospective Study of the BioFreedom Biolimus A9 Drug Coated Stent in Patients at High Risk for Bleeding 36
BioFreedom Ultra – BioFreedom Ultra Stent in Hong Kong All Comers Registry 36
BioFreedom Ultra – Comparison of Polymer-free Cobalt-Chromium Thin Drug-coated Stents with Biodegradable Polymer Ultrathin Sirolimus-Eluting Stents and Prasugrel Monotherapy with Conventional 12-Month Dual Antiplatelet Therapy 36
BioFreedom Ultra – Evaluation of Effectiveness and Safety of Biofreedom Family Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study 37
BioFreedom Ultra – Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 37
BioFreedom Ultra – P2Y12 Inhibitor-based Single Antiplatelet Therapy Versus Conventional Dual Antiplatelet Therapy After Percutaneous Coronary Intervention With BioFreedom Ultra Drug-coated Stent for Unprotected Left Main Coronary Artery Disease (ULTRA-LM) 37
BioFreedom Ultra – 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 38
BioFreedom Ultra – 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 38
Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 39
Coronary Stent System – Product Status 39
Coronary Stent System – Product Description 39
Biotronik SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 40
ProGenic Pimecrolimus-eluting Coronary Stent System – Product Status 40
ProGenic Pimecrolimus-eluting Coronary Stent System – Product Description 40
Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41
JACTAX Drug Eluting Stent – Product Status 41
JACTAX Drug Eluting Stent – Product Description 41
SYNERGY 48 Stent – Product Status 42
SYNERGY 48 Stent – Product Description 42
SYNERGY XD Stent – Product Status 42
SYNERGY XD Stent – Product Description 43
TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System – Product Status 43
TAXUS Petal Bifurcation Paclitaxel-Eluting Stent System – Product Description 43
Boston Scientific Corp – Ongoing Clinical Trials Overview 44
SYNERGY XD Stent – Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study 45
Cardionovum GmbH Pipeline Products & Ongoing Clinical Trials Overview 46
DEBLIMUS – Product Status 46
DEBLIMUS – Product Description 46
PROTECT – Product Status 47
PROTECT – Product Description 47
ReNATURAL (M) – Product Status 47
ReNATURAL (M) – Product Description 48
ReNATURAL (P) – Product Status 48
ReNATURAL (P) – Product Description 48
Cardiorev Pte Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 49
Peptide-Eluting Coronary Stent – Product Status 49
Peptide-Eluting Coronary Stent – Product Description 49
Columbia University Pipeline Products & Ongoing Clinical Trials Overview 50
C3 Exoenzyme Coated Stent – Product Status 50
C3 Exoenzyme Coated Stent – Product Description 50
Concept Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 51
Abluminus DES+ – Product Status 51
Abluminus DES+ – Product Description 51
Concept Medical Inc – Ongoing Clinical Trials Overview 52
Abluminus DES+ – A Multicenter, Prospective, Study to Evaluate the Safety and Effcacy of the Abluminus DES+ in an All-Comers Population 53
Abluminus DES+ – A Post Market Registry of Abluminus Sirolimus Eluting Coronary Stent System for Percutaneous Intervention in Patients with Diabetes Mellitus 53
Abluminus DES+ – ABILITY Diabetes Global 53
Abluminus DES+ – ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) – First in Men 54
Abluminus DES+ – Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus 54
Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 55
Corio Pimecrolimus-Eluting Stent – Product Status 55
Corio Pimecrolimus-Eluting Stent – Product Description 55
Cypher Elite – Product Status 56
Cypher Elite – Product Description 56
NEVO Sirolimus-Eluting Coronary Stent – Product Status 56
NEVO Sirolimus-Eluting Coronary Stent – Product Description 57
Next Generation Coronary Stent – Product Status 57
Next Generation Coronary Stent – Product Description 57
DISA Vascular (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 58
Stellium Stent – Product Status 58
Stellium Stent – Product Description 58
Elixir Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 59
DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System – Product Status 59
DESolve Myolimus Eluting Bioresorbable Coronary Scaffold System – Product Description 59
DynamX Drug Eluting Coronary Bioadaptor System – Product Status 60
DynamX Drug Eluting Coronary Bioadaptor System – Product Description 60
Myolimus Eluting Coronary Stent – Durable Polymer – Product Status 60
Myolimus Eluting Coronary Stent – Durable Polymer – Product Description 61
Elixir Medical Corp – Ongoing Clinical Trials Overview 62
DynamX Drug Eluting Coronary Bioadaptor System – DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System (Bio-RESTORE) 63
DynamX Drug Eluting Coronary Bioadaptor System – DYNAMX Bioadaptor Implantation for the Treatment of Complex Coronary Lesions (DYNAMITE Study) 63
DynamX Drug Eluting Coronary Bioadaptor System – Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De Novo Native Coronary Arteries ELX-CL-1805 63
DynamX Drug Eluting Coronary Bioadaptor System – Infinity-swedeheart Study: Registry Based Randomized Clinical Trial (R-RCT) Comparing Long Term Outcomes of the DynamX Bioadaptor to the Resolute Onyx Stent in a More-comer PCI Patient Population 64
Endomimetics LLC Pipeline Products & Ongoing Clinical Trials Overview 65
Coronary Artery Stent – Product Status 65
Coronary Artery Stent – Product Description 65
Envision Scientific Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 66
Paclitaxel Eluting Stent – Product Status 66
Paclitaxel Eluting Stent – Product Description 66
I.B.S. S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 67
Drug Eluting Stent – Product Status 67
Drug Eluting Stent – Product Description 67
InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 68
MGuard Drug Eluting Stent – Product Status 68
MGuard Drug Eluting Stent – Product Description 68
JW Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 69
Excel II DES – Product Status 69
Excel II DES – Product Description 69
Kaneka Corp Pipeline Products & Ongoing Clinical Trials Overview 70
MAHOROBA Stent – Product Status 70
MAHOROBA Stent – Product Description 70
MangoGen Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 71
Gene-Delivering Stent – Product Status 71
Gene-Delivering Stent – Product Description 71
Medinol Ltd Pipeline Products & Ongoing Clinical Trials Overview 72
IoNIR Ridaforolimus-Eluting Coronary Stent System – Product Status 72
IoNIR Ridaforolimus-Eluting Coronary Stent System – Product Description 72
Medinol Ltd – Ongoing Clinical Trials Overview 73
IoNIR Ridaforolimus-Eluting Coronary Stent System – IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System 74
IoNIR Ridaforolimus-Eluting Coronary Stent System – IonMAN Trial-First In Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System 74
Medlogics Device Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 75
COBRA-Q Drug Eluting Stent – Product Status 75
COBRA-Q Drug Eluting Stent – Product Description 75
SYNERGY – Product Status 76
SYNERGY – Product Description 76
Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 77
Drug Filled Stent – Product Status 77
Drug Filled Stent – Product Description 78
Resolute Onyx DES – DAPT – Product Status 78
Resolute Onyx DES – DAPT – Product Description 78
Medtronic Plc – Ongoing Clinical Trials Overview 79
Resolute Onyx DES – DAPT – BIOTRONIK- A Prospective, Randomised, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to Resolute Onyx Stent in Subjects at High Risk of Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT) 80
MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 81
Fantasy Drug-Eluting Stent – Product Status 81
Fantasy Drug-Eluting Stent – Product Description 81
Firebird Pro+ – Product Status 82
Firebird Pro+ – Product Description 82
Firebird2 Pro – Product Status 82
Firebird2 Pro – Product Description 82
Firehawk Plus – Product Status 83
Firehawk Plus – Product Description 83
MicroPort Scientific Corp – Ongoing Clinical Trials Overview 84
Firehawk Plus – LARGE-ONE: A Prospective, Multicenter, Randomized Controlled Trial of the Use of Drug-coating Balloons(DCB) or Drug-eluting Stents(DES) in the Treatment of Large Diameter Coronary Atherosclerotic Lesions 85
MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 86
Smart-2 DES – Product Status 86
Smart-2 DES – Product Description 86
Smart-3 DES – Product Status 87
Smart-3 DES – Product Description 87
Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 88
Liquid Drug Eluting Stent – Product Status 88
Liquid Drug Eluting Stent – Product Description 88
NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 89
NuSpun DE Stent Sheath – Product Status 89
NuSpun DE Stent Sheath – Product Description 89
Relisys Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 90
Corel + C Drug Eluting Stent – Product Status 90
Corel + C Drug Eluting Stent – Product Description 90
REVA Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 91
ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold – Product Status 91
ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold – Product Description 91
ReZolve2 Drug Eluting Bioresorbable Coronary Scaffold – Product Status 92
ReZolve2 Drug Eluting Bioresorbable Coronary Scaffold – Product Description 92
Shandong Rientech Medical Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 93
Absorbable Zinc Alloy Drug Eluting Coronary Stent System – Product Status 93
Absorbable Zinc Alloy Drug Eluting Coronary Stent System – Product Description 93
Shandong Rientech Medical Tech Co Ltd – Ongoing Clinical Trials Overview 94
Absorbable Zinc Alloy Drug Eluting Coronary Stent System – Exploratory Study on the Safety and Effectiveness of Absorbable Zinc Alloy Drug-eluting Coronary Stent System 95
Shanghai BIOMAGIC Medical Device Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 96
BIOMAGIC Biroresorbable Coronary Stent – Product Status 96
BIOMAGIC Biroresorbable Coronary Stent – Product Description 96
Shanghai MicroPort Medical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 97
Firehawk Rapamycin Target Eluting Coronary Stent System – Product Status 97
Firehawk Rapamycin Target Eluting Coronary Stent System – Product Description 97
Shanghai MicroPort Medical Group Co Ltd – Ongoing Clinical Trials Overview 98
Firehawk Rapamycin Target Eluting Coronary Stent System – A Prospective Multi-center Open-label Controlled Trial of Comparison 3 Versus 12 Months of Dual Anti-platelet Therapy after Implantation of Firehawk Sirolimus Target- eluting Stent in Patients with Stable Coronary Artery Disease 99
Firehawk Rapamycin Target Eluting Coronary Stent System – A Prospective, Multicenter, Single-arm Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in Patients with Coronary Artery Stenosis 99
Firehawk Rapamycin Target Eluting Coronary Stent System – A Prospective, Open Label, Multi-center Trial of Firehawk Coronary Stent System in the Treatment of Coronary Chronic Total Artery Occlusion Lesion(S) by Optical Coherent Tomography (OCT) and Coronary Angiography 99
Firehawk Rapamycin Target Eluting Coronary Stent System – Assessment of In-stent Intimal Repair and Vessel Reaction After Firehawk Sirolimus Eluting Stent Implantation of STEMI Subjects – An Optical Coherence Tomography (OCT) Study 100
Firehawk Rapamycin Target Eluting Coronary Stent System – Evaluation of Effectiveness and Safety of the First, Second, and New Drug-eluting Stents in Routine Clinical Practice 100
Firehawk Rapamycin Target Eluting Coronary Stent System – LARGE-ONE: A Prospective, Multicenter, Randomized Controlled Trial of the Use of Drug-coating Balloons(DCB) or Drug-eluting Stents(DES) in the Treatment of Large Diameter Coronary Atherosclerotic Lesions 100
Firehawk Rapamycin Target Eluting Coronary Stent System – Optical Coherence Tomography Compared with Intravascular Ultrasound or Quantitative Coronary Analysis to Guide Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery 101
Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 102
BuMA Supreme DES (Drug Eluting Stent) – Product Status 102
BuMA Supreme DES (Drug Eluting Stent) – Product Description 103
Supreme HT Drug-Eluting Stent – Product Status 103
Supreme HT Drug-Eluting Stent – Product Description 103
Sino Medical Sciences Technology Inc – Ongoing Clinical Trials Overview 104
BuMA Supreme DES (Drug Eluting Stent) – A Prospective, Multicenter First-in-man Trial Program in China to Evaluate the Efficacy and Safety of Buma Supreme (Eg Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Subjects with De Novo Coronary Lesions, RCT Trial 105
BuMA Supreme DES (Drug Eluting Stent) – A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients with de Novo Coronary Lesions, OPC Trial 105
Supreme HT Drug-Eluting Stent – A Prospective, Multi-center, Single-group Target Value Post-marketing Clinical Study to Evaluate the Safety and Effectiveness of the HT Supreme Drug-eluting Stent System in the Treatment of “Real-world” Patients with Coronary Heart Disease 106
Supreme HT Drug-Eluting Stent – Non-inferiority of Angiography-derived Physiology Guidance Versus Usual Care in an All-comers PCI Population Treated with Unrestricted Use of the Healing-targeted Supreme (HT Supreme) Drug-eluting Stent and P2Y12 Inhibitor Monotherapy after 1-month of Dual-antiplatelet Therapy 106
Stentys SA Pipeline Products & Ongoing Clinical Trials Overview 107
STENTYS Paclitaxel-Eluting Stent – Product Status 107
STENTYS Paclitaxel-Eluting Stent – Product Description 107
Svelte Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 108
DIRECT RX – Product Status 108
DIRECT RX – Product Description 109
Svelte Medical Systems Inc – Ongoing Clinical Trials Overview 110
DIRECT RX – OPTIMIZE Sirolimus-eluting Coronary Stent Systems Pharmacokinetics (PK) Study 111
Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 112
Ultimaster Nagomi – Product Status 112
Ultimaster Nagomi – Product Description 113
Terumo Corp – Ongoing Clinical Trials Overview 114
Ultimaster Nagomi – A Post-Market Clinical Follow-up Study With Ultimaster Nagomi Sirolimus Eluting Coronary Stent System in Complex PCI Subjects 115
Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 116
Next Generation Ultimaster Drug Eluting Bioresorbable Scaffold – Product Status 116
Next Generation Ultimaster Drug Eluting Bioresorbable Scaffold – Product Description 116
Next Ultimaster Metallic Drug Eluting Stent – Product Status 117
Next Ultimaster Metallic Drug Eluting Stent – Product Description 117
TissueGen Inc Pipeline Products & Ongoing Clinical Trials Overview 118
Cardiovascular Stent – Product Status 118
Cardiovascular Stent – Product Description 118
Translumina Therapeutics LLP Pipeline Products & Ongoing Clinical Trials Overview 119
VIVO ISAR-Sirolimus Eluting Coronary Stent System – Product Status 119
VIVO ISAR-Sirolimus Eluting Coronary Stent System – Product Description 120
Translumina Therapeutics LLP – Ongoing Clinical Trials Overview 121
VIVO ISAR-Sirolimus Eluting Coronary Stent System – A Prospective, Post Marketing Clinical Follow up Study to Evaluate the Safety and Performance of Polymer Free Sirolimus Eluting Coronary Stent System in Real World Indian Population 122
University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 123
Drug-Eluting Stent – Product Status 123
Drug-Eluting Stent – Product Description 123
VasoTech Inc. Pipeline Products & Ongoing Clinical Trials Overview 124
PowerStent Coro DES – Product Status 124
PowerStent Coro DES – Product Description 124
Glossary 152