Resolute onyx

Manufactured by Medtronic

Sourced in United States

The Resolute Onyx is a laboratory equipment product manufactured by Medtronic. It is designed to perform specific laboratory tasks, but a detailed and unbiased description is not available at this time.

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Lab products found in correlation

Xience, by Abbott (5 mentions) Orsiro, by Biotronik (4 mentions) Promus element, by Boston Scientific (3 mentions) Resolute integrity, by Medtronic (3 mentions) Ultimaster, by Terumo (3 mentions) Xience xpedition, by Abbott (2 mentions) Xience prime, by Abbott (2 mentions) Promus premier, by Boston Scientific (2 mentions) Promus element plus, by Boston Scientific (1 mentions) Nobori, by Terumo (1 mentions) Promus, by Boston Scientific (1 mentions) Sequent please, by B. Braun (1 mentions) Xience alpine, by Abbott (1 mentions) Sequent please neo, by B. Braun (1 mentions)

13 protocols using resolute onyx

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.

Buccheri S., James S., Lindholm D., Fröbert O., Olivecrona G.K., Persson J., Hambraeus K., Witt N., Erlinge D., Angerås O., Lagerqvist B, & Sarno G. (2019). Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR). European heart journal, 40(31).

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Feasibility of Diagnostic Angiography and PCI

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The primary outcome of the study was the feasibility of diagnostic angiography and PCI. A diagnostic angiogram was considered feasible if complete opacification of the coronary vessels was obtained following contrast media injection. A PCI was considered feasible if the vessel was successfully wired distally, a 2.5 mm × 20 mm semi-compliant balloon (Euphora, Boston Scientific, USA) was inflated, followed by successful advancement and retraction of a 3.5 mm × 20 mm drug-eluting stent (Resolute Onyx, Medtronic) in the proximal segment of the vessel.
The secondary outcome was to determine the incidence of challenging diagnostic catheter (DC) and guiding catheter (GC) cannulation, defined as, if for at least one operator either of the two criteria were met:
In addition, the association between challenging cannulations with the imaging variables derived from the pre and post-procedural CT scans was evaluated.

Khokhar A.A., Ponticelli F., Zlahoda-Huzior A., Chandra K., Ruggiero R., Toselli M., Gallo F., Cereda A., Sticchi A., Laricchia A., Regazzoli D., Mangieri A., Reimers B., Biscaglia S., Tumscitz C., Campo G., Mikhail G.W., Kim W.K., Colombo A., Dudek D, & Giannini F. (2022). Coronary access following ACURATE neo implantation for transcatheter aortic valve-in-valve implantation: Ex vivo analysis in patient-specific anatomies. Frontiers in Cardiovascular Medicine, 9, 902564.

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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).

Kim K.A., Her S.H., Lee K., Choi I.J., Lee J.H., Lee J.H., Lee S.R., Lee P.H., Lee S.W., Yoo K.D., Lee S.N., Jang W.Y., Moon D., Moon K.W., Yun K.H, & Lee H.J. (2022). Clinical Outcomes of Biodegradable versus Durable Polymer Drug Eluting Stents in Rotational Atherectomy: Results from ROCK Registry. Journal of Clinical Medicine, 11(21), 6251.

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BiOSS LIM C vs. Regular DES

Cited 1 time

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This was a multicenter (two centers in Poland) randomized, controlled study that enrolled patients between 2018 and 2020. Patients were enrolled if an informed consent form was signed and all inclusion criteria and no exclusion criteria were met. The inclusion and exclusion criteria are provided in Table 1 [14 (link)].
Patients were randomized 1:1 to a BiOSS LIM C stent group versus a regular DES (rDES) group. The following rDESs were used: Xience (Abbott Laboratories, Warsaw, Poland), Resolute Onyx (Medtronic Poland, Warsaw, Poland), Orsiro (Biotronik Polska, Poznan, Poland), Synergy (Boston Scientific Polska, Warsaw, Poland), and Promus Elite (Boston Scientific). This study’s protocol was compliant with SPIRIT guidelines [15 (link)]. An independent Ethics Committee approved the study protocol (No. 14/2018) (ClinicalTrials.gov NCT03548272).

Gil R.J., Kern A., Bojko K., Gziut-Rudkowska A., Vassilev D, & Bil J. (2024). The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results. Biomedicines, 12(5), 938.

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Thromboresistance of Coated Stents in COVID-19

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We tested the relative thromboresistance of stents coated with a fluorinated polymer (i.e. polyzene-F in COBRA-PzF (CeloNova, Carlsbad, CA)) versus the BioLinx polymer (i.e. C10, C19 and polyvinyl-pyrrolidinone polymers in Resolute Onyx (Medtronic, Minneapolis, MN)), and versus a bioabsorbable polymer (i.e. polylactic-co-glycolic acid in Synergy (Boston Scientific, Marlborough, MA)) (Table 1). Human blood was treated with TNF-α and IL-6 at levels consistent with what is seen in severe COVID-19 infections. Untreated blood served as control. The blood was circulated in a flow loop model, and stents were examined using confocal microscopy.Table 1

Stent characteristics.

Table 1

	Coated COBRA-PzF	Uncoated COBRA	Resolute Onyx	Synergy
Manufacturer	CeloNova	CeloNova	Medtronic	Boston Scientific
Stent material	L-605 cobalt‑chromium CoCr alloy	L-605 cobalt‑chromium CoCr alloy	Platinum‑iridium alloy core and cobalt‑chromium alloy shell	Platinum‑chromium PtCr alloy
Polymer coating	Polyzene-F [poly-bis(trifluoroethoxy) phosphazene]	None	BioLinx® (C10, C19, and polyvinyl-pyrrolidinone polymer blend)	Synchrony™ PLGA [poly(DL-lactide-co-glycolide)]; abluminally only
Strut thickness	71 μm	71 μm	81 μm	79 μm
Polymer thickness	0.050 μm	–	5.6 μm	4 μm
Drug component	–	–	Zotarolimus	Everolimus

Cornelissen A., Kutyna M., Cheng Q., Sato Y., Kawakami R., Sakamoto A., Kawai K., Mori M., Fernandez R., Guo L., Pellegrini D., Guagliumi G., Barakat M., Virmani R, & Finn A. (2021). Effects of Simulated COVID-19 Cytokine Storm on Stent Thrombogenicity. Cardiovascular Revascularization Medicine, 35, 129-138.

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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.

Azzalini L., Giustino G., Ojeda S., Serra A., La Manna A., Ly H.Q., Bellini B., Benincasa S., Chavarría J., Gheorghe L.L., Longo G., Miccichè E., D'Agosta G., Picard F., Pan M., Tamburino C., Latib A., Carlino M., Chieffo A, & Colombo A. (2016). Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions: The BONITO Registry (Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions). Circulation. Cardiovascular interventions, 9(10).

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Comparison of BiOSS LIM C and DES in Bifurcation PCI

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Five hundred eighteen patients with symptomatic stable coronary artery disease or NSTE-ACS qualified for PCI in non-LM coronary bifurcation will be screened, and enrolled if informed consent form is signed and all inclusion criteria and none exclusion criteria are met. Inclusion criteria and exclusion criteria are detailed in Table 1.
Subjects will be 1:1 randomized to a BiOSS LIM C stent versus DES group. The following DES will be allowed: Xience (Abbott Laboratories, Chicago, IL), Resolute Onyx (Medtronic, Dublin, Ireland), Orsiro (Biotronik, Berlin, Germany), and Synergy (Boston Scientific, Marlborough, MA). Patients will be followed, according to the protocol (ClinicalTrials.gov NCT03548272) (Fig. 1). Study protocol is compliant with SPIRIT guidelines.^{[13 (link)]} Independent Ethics Committee approved the study protocol (No. 14/2018).

Gil R.J., Pawłowski T., Legutko J., Lesiak M., Witkowski A., Gąsior M., Kern A, & Bil J. (2019). Rationale and design of the randomized, multicenter, open-label, controlled POLBOS 3 trial aimed to compare regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM C stent. Medicine, 98(14), e15106.

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Retrospective Analysis of ACS Patients with EES or R-ZES

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We retrospectively analyzed the ACTION-ACS, a pooled large patient ACS database involving
two interventional large-volume academic centers based in Poland: the Department of
Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, and the
Nicolaus Copernicus University, Bydgoszcz, Poland. Information on the follow-up events was
site-reported and adjudicated by a trained physician-investigator. Data of consecutive
patients with ACS, undergoing PCI with EES (Xience, Abbott Vascular, Santa Clara, CA, USA
and Promus Element, Boston Scientific, Natick, MA, USA) or R-ZES (Resolute Integrity,
Resolute Onyx, Medtronic, Fridley, MN, USA), were collected between November 2009 and
February 2017 (Figure 1). Relevant
baseline information, procedural, and clinical outcomes at follow-up were entered into
prespecified electronic case report forms. Angioplasty and stent selection were performed
according to standard techniques at the discretion of the interventional cardiologist. All
patients were prescribed dual antiplatelet therapy (DAPT) consisting of acetylsalicylic
acid, 75 to 100 mg daily, and a P2Y12 inhibitor for at least 1 year according to
guidelines.

Koni E., Wanha W., Ratajczak J., Zhang Z., Podhajski P., Musci R.L., Sangiorgi G.M., Kaźmierski M., Buffon A., Kubica J., Wojakowski W, & Navarese E.P. (2021). Five-Year Comparative Efficacy of Everolimus-Eluting vs. Resolute Zotarolimus-Eluting Stents in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. Journal of Clinical Medicine, 10(6), 1278.

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Resolute Onyx Zotarolimus-Eluting Stent Design

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Resolute Onyx™ (Medtronic Inc., Santa Rosa, CA, USA) is a zotarolimus-eluting stent designed for higher procedural success and better acute performance. The design is based on its predecessor, the Resolute™ Integrity drug-eluting stent, which was extensively studied in the Resolute Global Clinical Program.^{3 (link)} In brief, the stent is manufactured using continuous sinusoid technology that employs a single strand of wire to form a sinusoidal pattern of crowns, which is laser fused at selected crowns. This distinctive wire-forming facilitates smooth tracking in tortuous vessels and allows excellent conformability.^{5 (link)} The drug polymer BioLinx is highly biocompatible with a hydrophilic surface designed to minimize inflammation.^{6 (link)} The polymer elutes the drug zotarolimus, which is a synthetic analogue of sirolimus, over 180 days, with >85% of the zotarolimus dose released by day 60.^{7 (link)} The latest version Resolute Onyx™ utilizes core-wire technology in which the cobalt alloy incorporates a platinum iridium core for increased radiopacity. Moreover, the strut thickness is further reduced to 81 µm (0.0032 inches) with maintained radial strength and the crossing profile is 0.037 mm for the 2.5 mm stent. The Resolute Onyx™ stents used in patients included in this registry study ranged from 2.0 mm to 5.0 mm diameters and the stent lengths were up to 38 mm.

Tam C.C., Chan K., Lam S., Yung A., Lam Y.M., Chan C., Siu D, & Tse H.F. (2017). One-year clinical outcomes of patients implanted with a Resolute Onyx™ zotarolimus-eluting stent. The Journal of International Medical Research, 46(1), 457-463.

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Comparison of Small Vessel DCBs and DESs

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The available DCBs at our institution with nominal diameters of 2.0 mm and 2.25 mm for very small vessel lesions were SeQuent Please, SeQuent Please Neo (B. Braun, Berlin, Germany), and Agent (Boston Scientific, Wurselen, Germany). The available DESs with stent diameters of 2.0 mm and 2.25 mm for very small vessel lesions were sirolimus-eluting Orsiro (Biotronik, Buloch, Switzerland), everolimus-eluting Synergy (Boston Scientific, Galway, Ireland), Xience Alpine (Abbott Vascular, Tipperary, Ireland), and zotarolimus-eluting Resolute Onyx (Medtronic, Galway, Ireland). The choice of device was left to the operator or according to the patient’s preference.

Tsai C.H., Yeh C.F., Meng S.W., Hung C.S., Lin M.S., Huang C.C., Chen C.K., Huang K.P., Chen Y.H, & Kao H.L. (2022). Comparison between drug-coated balloons and drug-eluting stents in very small coronary artery interventions. Scientific Reports, 12, 10679.

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