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AtCor Sphygmocor Xcel
Device Name:
Sphygmocor Xcel
Manufacturer:
Atcor Medical, Unit 11, West Ryde Corporate Centre, 1059-1063 Victoria Rd, West Ryde, NSW 2114, AUSTRALIA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use including central aortic pressure
Measurement Site:
Radial Artery
Measurement Occurrence:
Continuous measurement
Availability:
Available Currently
Description:
The AtCor Sphygmocor Xcel is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the radial artery. It is intended for professional use including central aortic pressure.
Assessment:
The technology used in the AtCor Sphygmocor Xcel, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Validation Publications:

Shoji T, Nakagomi A, Okada S, Ohno Y, Kobayashi Y. Invasive validation of a novel brachial cuff-based oscillometric device (SphygmoCor XCEL) for measuring central blood pressure. J Hum Hypertens. 2017 Jan;35(1):69-75. doi: 10.1097/HJH.0000000000001135. PMID: 27763994.

IA protocol General population

Schultz MG, Picone DS, Armstrong MK, Black JA, Dwyer N, Roberts-Thomson P, Sharman JE. Validation Study to Determine the Accuracy of Central Blood Pressure Measurement Using the Sphygmocor Xcel Cuff Device. Hypertension. 2020 Jul;76(1):244-250. Epub: 2020 Jun 1. doi: 10.1161/HYPERTENSIONAHA.120.14916. PMID: 32475318.

IA protocol - Fail General population (Note: Default brachial SBP and DBP calibration)

IA protocol - Fail General population (Note: 33% form-factor MAP and DBP calibration)

IA protocol - Fail General population (Note: 40% form-factor MAP and DBP calibration)

IA protocol - Fail General population (Note: Oscillometric MAP and DBP calibration)

IA protocol - Pass General population (Note: (Invasive central integrated MAP and DBP calibration))

Mynard JP, Goldsmith G, Springall G, Eastaugh L, Lane GK, Zannino D, Smolich JJ, Avolio A, Cheung MMH. Central aortic blood pressure estimation in children and adolescents: results of the KidCoreBP study. J Hypertens. 2020 May;38(5):821-828. doi: 10.1097/HJH.0000000000002338. PMID: 31790068.

IA protocol - Fail Children and adolescents, aged 3 to 18 years (n=62) (Note: Failed SBP)

De la Torre Hernández JM, Veiga Fernandez G, Brown J, Sainz Laso F, Lee DH, Fradejas V, Garcia Camarero T, Elmariah S, Inglessis I, Zueco J, Vazquez de Prada JA, Ben-Assa E, Edelman ER. Validation study to determine the accuracy of central blood pressure measurement using the SphygmoCor XCEL cuff device in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. J Clin Hypertens (Greenwich). 2021 Jun;23(6):1165-1175. Epub: 2021 May 4. doi: 10.1111/jch.14245. PMID: 33942487. Available from: onlinelibrary.wiley.com.

ARTERY Society protocol:2017 - Fail Pre-TAVR non-invasive aortic SBP (SphygmoCor XCEL) v invasive aortic SBP

ARTERY Society protocol:2017 - Fail Post-TAVR non-invasive aortic SBP (SphygmoCor XCEL) v invasive aortic SBP

ARTERY Society protocol:2017 - Fail Pre-TAVR non-invasive brachial SBP (SphygmoCor XCEL) v invasive aortic SBP

ARTERY Society protocol:2017 - Fail Post-TAVR non-invasive brachial SBP (SphygmoCor XCEL) v invasive aortic SBP

(TAVR transcatheter aortic valve replacement)

Relevant Publications:

Gotzmann M, Hogeweg M, Seibert FS, Rohn BJ, Bergbauer M, Babel N, Bauer F, Mügge A, Westhoff TH. Accuracy of fully automated oscillometric central aortic blood pressure measurement techniques. J Hypertens. 2020 Feb;38(2):235-242. Epub: 2019 Sep 9. doi: 10.1097/HJH.0000000000002237. PMID: 31503132.

Measurements from the AtCor Sphygmocor Xcel are compared to those from the IEM Mobil-O-Graph NG, though not in a formal validation.

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