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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.
Assessment:

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)