The second-and third-generation DESs were defined as everolimus-eluting stents with a durable polymer (Xience [Abbott Vascular, Santa Clara, California] and Promus [Boston Scientific, Natick, Massachusetts]), zotarolimus-eluting stents with a durable polymer (Resolute [Medtronic, Minneapolis, Minnesota]), everolimus-eluting stents with a bioabsorbable polymer (Synergy [Boston Scientific, Natick, Massachusetts]), biolimus-eluting stents with a biodegradable polymer (Nobori [Terumo, Tokyo, Japan]), Ultimaster sirolimus-eluting stents with a biodegradable polymer (Ultimaster [Terumo, Tokyo, Japan] and Orsiro [Biotronik, Bülach, Switzerland]), Biomatrix biolimus A9 (BA9)-eluting stents with a biodegradable polymer, and BioFreedom BA9-coated stents (Biosensors, Newport Beach, California) [3 (link)].
Ultimaster
Manufactured by Terumo
Sourced in Japan, United States
The Ultimaster is a medical device used in laboratories for various applications. It serves as a versatile and high-performance piece of equipment that can be utilized in various laboratory settings. The core function of the Ultimaster is to provide reliable and consistent performance for the tasks it is designed to support.
Automatically generated - may contain errors
Lab products found in correlation
Xience prime, by Abbott (3 mentions)
Resolute onyx, by Medtronic (3 mentions)
Nobori, by Terumo (3 mentions)
Promus element, by Boston Scientific (2 mentions)
Xience xpedition, by Abbott (2 mentions)
Promus premier, by Boston Scientific (2 mentions)
Resolute integrity, by Medtronic (2 mentions)
Xience, by Abbott (2 mentions)
Promus, by Boston Scientific (2 mentions)
Promus element plus, by Boston Scientific (1 mentions)
Xience alpine, by Abbott (1 mentions)
Orsiro, by Biotronik (1 mentions)
12 protocols using ultimaster
1
Comparative Analysis of Drug-Eluting Stents
2
Ultimaster Stent Performance in Daily Practice
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The e-Ultimaster registry (NCT02188355) was an all-comer, single-arm, prospective, multicentre study, with clinical follow-up at 3 months and 1 year, evaluating the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer (Ultimaster; Terumo Corporation, Tokyo, Japan) in daily practice. Patients were enrolled between October 2014 and June 2018 in 378 hospitals from 50 countries (online supplemental table 1 ). Follow-up was performed at 3 months at 1 year, by phone or hospital visit. Information collected included vital status, occurrence of adverse events, angina status, antiplatelet medication and other cardiac medication. Sites were instructed to attempt three phone calls and one contact by letter to obtain follow-up information before patient was considered lost to follow-up. For the purpose of the analysis, countries were grouped in four geographical regions: Europe, Asia, South America/Mexico and Africa/Middle East (online supplemental figure 1 and online supplemental table 2 ). No patient or public was involved in the design or execution of the study.
3
Comparative Analysis of Newer Generation DES Platforms
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For this analysis, we stratified newer generation DES with at least 1000 implants into BP-and PP-DES groups. The BP-DES group included the Synergy (Boston Scientific Corporation, Marlborough, MA, USA), Orsiro (Biotronik AG, Bu ¨lach, Switzerland), and Ultimaster (Terumo Corporation, Tokyo, Japan) stent platforms. Characteristics of different BP-DES used in this study are shown in the Supplementary material online, Table S1. The PP-DES group included: Xience Prime and Xience Xpedition (Abbott Vascular, Santa Clara, CA, USA); Promus Element, Promus Element Plus and Promus Premier (Boston Scientific, Natick, MA, USA); Resolute Integrity and Resolute Onyx (Medtronic Inc., Minneapolis, MN, USA).
To more broadly reflect the current clinical practice, the thick and non-contemporary Biomatrix stent (Biosensors Interventional Technologies Pte Ltd, Singapore) was excluded from the analysis. To avoid double counting of patients, only the first registered PCI procedure during the inclusion period was selected for the analysis. Also, patients implanted with a mixture of different stent types at the index procedure were excluded.
To more broadly reflect the current clinical practice, the thick and non-contemporary Biomatrix stent (Biosensors Interventional Technologies Pte Ltd, Singapore) was excluded from the analysis. To avoid double counting of patients, only the first registered PCI procedure during the inclusion period was selected for the analysis. Also, patients implanted with a mixture of different stent types at the index procedure were excluded.
4
Strategies for Coronary Stent Implantation
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The stents used in the present study were sirolimus-eluting stents (SES) (Cypher family, Cordis Corporation, Johnson & Johnson, Warren, NJ, USA, and Ultimaster; Terumo Corporation, Tokyo, Japan), paclitaxel-eluting stent (Taxus family, Boston Scien-tific, Natick, MA, USA), zotarolimus-eluting stents (Endeavor family and Resolute family, Medtronic, Santa Rosa, CA, USA), everolimus-eluting stents (Xience family [Abbott Vascular, Santa Clara, CA, USA], Promus family and Synergy [Boston Scientific, Natick, MA, USA]), and biolimus-eluting stent (Nobori, Terumo Corporation, Tokyo, Japan). In this study, cDES included Ultimaster, Resolute family, Xience family, Promus family, Synergy, and Nobori.
Single-stent strategy (SSS) was defined as the use of a single stent, regardless of the lesion type. A double-stent strategy (DSS) was defined as the use of 2 stents, regardless of the technique used. This study included the provisional strategies with DSS, such as the crush, mini-crush, culotte, T and protrusion, T-stenting, V-stenting, and kissing stenting. The main strategy of stenting was decided at the operator's discretion. Kissing balloon inflation and proximal optimization technique (POT) after stent implantation were also dependent on the operator's discretion.
Single-stent strategy (SSS) was defined as the use of a single stent, regardless of the lesion type. A double-stent strategy (DSS) was defined as the use of 2 stents, regardless of the technique used. This study included the provisional strategies with DSS, such as the crush, mini-crush, culotte, T and protrusion, T-stenting, V-stenting, and kissing stenting. The main strategy of stenting was decided at the operator's discretion. Kissing balloon inflation and proximal optimization technique (POT) after stent implantation were also dependent on the operator's discretion.
5
Comparative Evaluation of Durable and Bioresorbable Coronary Stents
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Three different types of DESs were implanted into 17 mini-pigs (Japan Farm Co., Ltd., Kagoshima, Japan) (Fig. 1 ): DP-EESs (XIENCE Prime™; Abbott Vascular, Tokyo, Japan; n = 8), BP-SESs (Ultimaster™; Terumo Corp., Tokyo, Japan; n = 8), and BMSs (Kaname; Terumo Corp.; n = 8), with 1 of each type implanted into each pig (1 stent per vessel). The DP-EES is an everolimus-eluting stent with a uniform coating of durable fluoropolymer (polyvinylidene fluoride-co-hexafluoropropene) [26] . The BP-SES has an abluminal coating with a matrix containing sirolimus and poly (DL-lactide)-co-caprolactone [27] (link), [28] (link). The BP is completely metabolized into carbon dioxide and water within 3–4 months. The number of animals required was determined from previous work [29] (link). All animals were sacrificed at 9 months to investigate the early vascular response. The stents were then histologically examined. This study was approved and performed according to the guidelines of the Institutional Animal Care and Use Committee of R&D Headquarters at Terumo Corp.![]()
6
Comparison of Polymer-Coated Coronary Stents
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The SES (Ultimaster, Terumo Corporation, Tokyo, Japan) consists of the cobalt chromium (Co-Cr) coronary stent platform, a polymer coating (poly (D,L) lactic acid-polycaprolactone) and an antiproliferative agent, sirolimus. The stent strut thickness is 80 µm, with an abluminal gradient coating drug polymer matrix and the polymer degradation time of 3–4 months [7 (link)]. The BES (Nobori, Terumo Corporation, Tokyo, Japan) consists of a stainless steel stent platform, a bioresorbable polymer (polylactic acid) coating and an antiproliferative agent, Biolimus A9 (Biosensors International Ltd, Singapore) drug. The stent strut thickness is 120 µm, with an abluminal drug polymer matrix and a polymer degradation time of 9–12 months [9 (link)]. In the e-Ultimaster registry, the SES was available in six diameters (2.25, 2.5, 2.75, 3.0, 3.5 and 4.0 mm) and eight lengths (9, 12, 15, 18, 24, 28, 33 and 38 mm). In the Nobori 2 registry, the BES was available in three diameters (2.5, 3.0 and 3.5 mm) and five lengths (8, 14, 18, 24 and 28 mm) (Fig. 1 ).
7
Acute Coronary Syndrome Stent Comparison
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Thirty consecutive patients who underwent stent implantation (the CoCr-EES [XIENCE Alpine™; Abbott Vascular, Santa Clara, CA, USA], N = 10; BP-EES [Synergy™; Boston Scientific Corporation, Marlborough, MA, USA], N = 10; and BP-SES [Ultimaster™; Terumo Corp., Tokyo, Japan], N = 10) for acute coronary syndrome (ACS) were prospectively enrolled. Patients had ischemic chest discomfort with ST-segment elevation or depression of >0.5 mm or T-wave inversion in 2 or more leads. Acute myocardial infarction was diagnosed by increased troponin T levels, serum levels of creatine phosphokinase (more than twice the upper limit of normal), and creatine phosphokinase-MB fraction (>10% of the total creatine kinase). Patients without elevation of the creatine kinase-MB fraction were classified as having unstable angina.
Patients with the following criteria were excluded: cardiogenic shock, left main coronary artery disease, extremely tortuous or heavily calcified vessels, intolerance to antiplatelet drugs, in-stent restenosis after DES implantation, overlapped stenting, multiple stenting, and severe chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m2).
Patients with the following criteria were excluded: cardiogenic shock, left main coronary artery disease, extremely tortuous or heavily calcified vessels, intolerance to antiplatelet drugs, in-stent restenosis after DES implantation, overlapped stenting, multiple stenting, and severe chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m2).
8
Durable vs. Biodegradable Polymer DES Performance
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The following stents in the ROCK registry had durable polymers and were analyzed as the DP-DES group: 1. Xience (Abbott Vascular, Santa Clara, CA, USA), a cobalt chromium everolimus eluting stent (CoCr-EES) with strut thickness 81 μm. (n = 99) 2. Resolute Onyx (Medtronic, Santa Rosa, CA, USA), a zotarolimus eluting stent (ZES) with strut thickness 81 μm. (n = 61) 3. Endeavor (Medtronic, Santa Rosa, CA, USA), a ZES with strut thickness 91 μm. (n = 32) 4. Promus (Boston Scientific, Marlborough, MA, USA), a platinum chromium everolimus eluting stent (PtCr-EES) with strut thickness 81 μm (n = 80).
Meanwhile, the following stents in the ROCK registry had biodegradable polymers and were analyzed as the DP-DES group: 1. Ultimaster (Terumo, Tokyo, Japan), a cobalt chromium sirolimus eluting stent (CoCr-SES) with strut thickness 80 μm. (n = 44) 2. Orsiro (Biotronik, Berlin, Germany), a CoCr-SES with strut thickness 60 μm for stent diameter 2.25–3.0 mm and 80 μm for larger diameters. (n = 31) 3. Synergy (Boston Scientific, Marlborough, MA, USA), a platinum chromium everolimus eluting stent (PtCr-EES) with strut thickness 74 μm. (n = 150) 4. Nobori (Terumo, Tokyo, Japan), a stainless steel biolimus eluting stent (BES) with strut thickness 112 μm. (n = 6) 5. Biomatrix (Biosensors International, Morges, Switzerland), a CoCr-BES with strut thickness 83 μm (n = 7).
Meanwhile, the following stents in the ROCK registry had biodegradable polymers and were analyzed as the DP-DES group: 1. Ultimaster (Terumo, Tokyo, Japan), a cobalt chromium sirolimus eluting stent (CoCr-SES) with strut thickness 80 μm. (n = 44) 2. Orsiro (Biotronik, Berlin, Germany), a CoCr-SES with strut thickness 60 μm for stent diameter 2.25–3.0 mm and 80 μm for larger diameters. (n = 31) 3. Synergy (Boston Scientific, Marlborough, MA, USA), a platinum chromium everolimus eluting stent (PtCr-EES) with strut thickness 74 μm. (n = 150) 4. Nobori (Terumo, Tokyo, Japan), a stainless steel biolimus eluting stent (BES) with strut thickness 112 μm. (n = 6) 5. Biomatrix (Biosensors International, Morges, Switzerland), a CoCr-BES with strut thickness 83 μm (n = 7).
9
Bioresorbable Scaffolds vs. Drug-Eluting Stents in CTO PCI
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The only BRS used in this study was Absorb. However, several second-generation DES were used: Xience Prime, Xience Xpedition, and Xience Pro X (Abbott Vascular); Promus Premier, Promus Element and Synergy (Boston Scientific, Marlborough, MA); Resolute Integrity and Resolute Onyx (Medtronic, Minneapolis, MN); Nobori and Ultimaster (Terumo, Tokyo, Japan); BioMatrix (Biosensors International, Singapore); Combo (OrbusNeich, Hong Kong); Xposition S (Stentys, Paris, France); and Cre8 (Alvimedica, Istanbul, Turkey).
BRS implantation was performed as recommended by expert consensus (aggressive lesion preparation, appropriate sizing, routine intravascular imaging guidance, and high-pressure postdilatation with noncompliant balloons with a balloon-to-artery ratio of ≈1). 10 (link) DES implantation technique was left at the operator discretion. Figures 1 and2 show examples of CTO PCI with BRS and DES, respectively.
BRS implantation was performed as recommended by expert consensus (aggressive lesion preparation, appropriate sizing, routine intravascular imaging guidance, and high-pressure postdilatation with noncompliant balloons with a balloon-to-artery ratio of ≈1). 10 (link) DES implantation technique was left at the operator discretion. Figures 1 and2 show examples of CTO PCI with BRS and DES, respectively.
10
Evaluating Sirolimus-Eluting Stent Efficacy
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A prospective randomized double blinded trial has been designed to evaluate the effect of sirolimus-eluting stent (Ultimaster®, Terumo Corporation, Tokyo, Japan) implantation into the maximally dilated coronary artery. The trial protocol has been registered at http://www.clinicaltrials.gov (NCT04931784), and a brief flowchart of the entire study is presented in Fig. 1 .![]()
A flow-chart for the study. MI, myocardial infarction; PCI, percutaneous coronary intervention; SES, sirolimus-eluting stent; TVR, target vessel revascularization
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