iSYMED VascAssist 2
Device Name:
VascAssist 2
Manufacturer:
iSYMED Innovative Systeme in der Medizintechnik GmbH, Gebrueder-Freitag-Straße 1, 35510 Butzbach, GERMANY.
Measuring functions:
Blood Pressure and PR
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 an automatic blood pressure monitor. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. 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 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| 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:
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)