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iSYMED VascAssist 2

Device Name:VascAssist 2
Manufacturer:Sole: iSYMED Innovative Systeme in der Medizintechnik GmbH, Gebrueder-Freitag-Straße 1, 35510 Butzbach, GERMANY.
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 iSYMED VascAssist 2 is a clinically validated automatic blood pressure monitor. Measurements are taken from the radial artery and it is intended for professional use including central aortic pressure.

The technology used in the iSYMED VascAssist 2, to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a general population, according to a non-standard protocol.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications

Trinkmann F, Benck U, Halder J, Semmelweis A, Saur J, Borggrefe M, Akin I, Kaden JJ. Automated non-invasive central blood pressure measurements by oscillometric radial pulse wave analysis - results of the MEASURE-cBP validation studies. Am J Hypertens. 2021 Apr 20;34(4):383-39. Epub: 2020 Nov 3. doi: 10.1093/ajh/hpaa174. PMID: 33140085.

IA protocol - Fail n=106 (Note: Error 4 mmHg ± 12 mmHg / 6 mmHg ± 10 mmHg)

Ad Hoc protocol Comparison with Atcor Sphygmocor (n=119) (Note: Error +4 mmHg ± 4 mmHg / +1 mmHg ± 4 mmHg)