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EUROPEAN Device Guide / Coronary Balloon-Expandable Drug-Eluting Stents

Company Name Product Name Drug Delivered Material Used Polymer Type Maximum Guidewire Size (inch) Introducer Size (F) Stent Diameter (mm) Stent Length (mm) Delivery System Length (cm) CE Mark Indications
Rontis AG Abrax Sirolimus Carbonized stainless steel alloy Biodegradable PLGA 0.014 Guide catheter: 5 (minimum) 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4 10, 14, 18, 24, 28, 34, 38 142 Coronary
Balton Alex Plus Sirolimus Cobalt chromium PLGA 0.014 5 2, 2.25, 2.5, 2.75, 3, 3, 3.5, 3.75, 4, 4.5 8, 10, 12, 15, 18, 22, 25, 29, 34, 36, 38, 40 140
iVascular Angiolite Sirolimus Cobalt chromium (CoCr L605) Biostable fluorinated acrylate 0.014 5 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5 9, 14, 16, 19, 24, 29, 34, 39 142 Indicated for increasing the internal diameter of an artery with the aim of improving blood flow in the following cases: (1) patients with symptomatic ischemic heart disease due to de novo stenotic and restenotic lesions located in arteries with diameters from 2 to 4.5 mm; (2) patients with occlusive disease due to acute myocardial infarction located in arteries with diameters from 2 to 4.5 mm
Cordis, a Cardinal Health Company (manufactured by Biosensors) BioFreedom Drug-Coated Coronary Stent Biolimus Stainless steel 0.014 5 2.25, 2.5, 2.75, 3, 3.5, 4 8, 11, 14, 18, 24, 28, 33, 36 142 Improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging from 2.25 to 4 mm
Meril Life Sciences Pvt. Ltd. BioMime - Sirolimus Eluting Coronary Stent System Sirolimus Cobalt chromium L605 Biodegradable and biocompatible 0.014 5 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5 8, 13, 16, 19, 24, 29, 32, 37, 40, 44, 48 140–142
Meril Life Sciences Pvt. Ltd. BioMime Morph - Sirolimus Eluting Coronary Stent System Sirolimus Cobalt chromium L605 Biodegradable and biocompatible 0.014 5 2.75–2.25, 3–2.5, 3.5–3 30, 40, 50, 60 142
Balton Bioss Lim C Sirolimus Cobalt chromium PLGA 0.014 5 2.5/3; 2.5/3.25; 2.75/3.5; 3/3.5; 3/3.75; 3.5/4.25; 3.75/4.5; 16, 19, 24 140 Bifurcation-optimized stent for coronary vessels with one profiled balloon
Alvimedica Coracto Sirolimus 316 LVM stainless steel PLGA 0.014 5 (GC compatibility) 2.5, 2.75, 3, 3.5, 4 9, 13, 17, 21, 24, 28, 32 150
B. Braun Melsungen AG Coroflex ISAR NEO Sirolimus Cobalt-chromium alloy L605 0.014 5 (standard guiding catheter), 6 (kissing compatibility) 2, 2.25, 2.5, 2.75, 3, 3.5, 4 9, 12, 16, 19, 24, 28, 32, 38 145
Alvimedica Cre8 Amphilimus formulation: sirolimus + fatty acid L605 cobalt chromium alloy integrally coated by bio inducer surface 0.014 5 (GC compatibility) 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5 8, 12, 16, 20, 25, 31, 38, 46 142
Alvimedica Cre8 EVO Amphilimus formulation: sirolimus + fatty acid L605 cobalt chromium alloy integrally coated by bio inducer surface 0.014 5 (GC compatibility) 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5 9, 13, 16, 20, 26, 33, 40, 46 142
Cordis, a Cardinal Health Company (manufactured by Medinol Ltd.) EluNIR elastomeric DES Ridaforolimus Cobalt chromium PBMA and CarboSil 20 55D 0.014 5 2.5, 2.75, 3, 3.5, 4 8, 12, 15, 17, 20, 24, 28, 33, 38, 44 140 Improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions of length ≤ 42 mm in native coronary arteries with reference diameters of 2.5 to 4.25 mm
Meril Life Sciences Pvt. Ltd. Metafor - Sirolimus Eluting Coronary Stent System Sirolimus Cobalt chromium L605 Biodegradable and biocompatible 0.014 5 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5 8, 13, 16, 19, 24, 29, 32, 37, 40, 44, 48 140–142
Balton Prolim Sirolimus Stainless steel PLGA 0.014 5 2, 2.25, 2.5, 2.75; 3, 3.25, 3.5, 3.75, 4, 4.5, 5 8, 10, 12, 15, 18, 22, 25, 29, 34, 36, 38, 40 140
Boston Scientific Corporation Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System Everolimus Platinum chromium PVDF-HFP (poly-vinylidene fluoride-hexafluoropropylene) 0.014 Minimum guide catheter size: 5 ( ≥ 1.42 mm) 2.25, 2.5 2.75, 3, 3.5, 4 8, 12, 16, 20, 24, 28, 32, 38 144
Boston Scientific Corporation Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System Everolimus Platinum chromium PVDF-HFP (poly-vinylidene fluoride-hexafluoropropylene) 0.014 Minimum guide catheter size: 5 (MR: ≥ 1.42 mm) 2.25, 2.5, 2.75, 3, 3.5, 4 8, 12, 16, 20, 24, 28, 32, 38 MR: 144
Medtronic Resolute Integrity Zotarolimus-Eluting Stent System Zotarolimus Cobalt alloy BioLinx 0.014 Minimum guide catheter size: 5 (RX and OTW: ≥ 0.056 inch/1.42 mm) 2.25, 2.5, 2.75, 3, 3.5, 4 8, 9, 12, 14, 15, 18, 22, 23, 26, 30, 34, 38 RX: 140; OTW: 135 Coronary
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Zotarolimus Shell: cobalt alloy, core: platinum iridium BioLinx 0.014 Minimum guide catheter size: 5 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5 8, 12, 15, 18, 22, 26, 30, 34, 38 (2 mm not available in 34, 38 mm lengths; 4.5, 5 mm not available in 8, 34, 38 mm lengths) 140 Coronary
Abbott Xience Alpine Everolimus-Eluting Coronary Stent System Everolimus Cobalt chromium Fluoropolymer 0.014 Minimum guide catheter size: 5 (RX and OTW): (≥ 0.056 inch/1.42 mm); 4-mm diameter: 6 (≥ 1.68 mm) 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4 8, 12, 15, 18, 23, 28, 33, 38 145
Abbott Xience Sierra Everolimus-Eluting Coronary Stent System Everolimus Cobalt chromium Fluoropolymer 0.014 Minimum guide catheter size: 5 (RX and OTW: ≥ 0.056 inch/1.42 mm); 4-mm diameter: 6 (≥ 1.68 mm) 2.0, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4 8, 12, 15, 18, 23, 28, 33, 38 145 Coronary
Cardionovum GmbH Xlimus Sirolimus drug elution Cobalt chromium alloy L-605 Biodegradable PLA 0.014 5–6 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5 8, 12, 16, 20, 24, 28, 32, 36, 40 140 Symptomatic ischemic heart disease deriving from de novo lesions in native coronary arteries; acute myocardial infarction for restoring coronary blood flow; concomitant conditions: diabetes, acute coronary syndrome, lesions in two vessels, and smaller coronary arteries

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