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DiaTecne PulsePen (V1)

Device Name:PulsePen
Manufacturer:Sole: DiaTecne s.r.l., Via Giuseppe di Vittorio 190, San Donato Milanese, Milano 20097, ITALY.
Measuring functions:Blood pressure, Pulse wave velocity
Primary Client Use:Intended for professional use including central aortic pressure
Measurement Site:Upper Arm, Wrist, Thigh, Calf, Foot, Neck (Brachial, Radial, Femoral, Tibial, Dorsalis Pedis, Carotid arteries)
Measurement Occurrence:Continuous measurement over at least 10 cardiac cycles
Description: The DiaTecne PulsePen (V1) is a clinically validated automatic arterial applanation tonometry based blood pressure monitor. Measurements are taken from the upper arm or abdomen and it is intended for professional use including central aortic pressure. This device is now obsolete.

The technology used in the DiaTecne PulsePen (V1), to measure blood pressure, has 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

Salvi P, Lio G, Labat C, Ricci E, Pannier B, Benetos A. Validation of a new non-invasive portable tonometer for determining arterial pressure wave and pulse wave velocity: the PulsePen device. J Hypertens. 2004 Dec;22(12):2285-2293. doi: 10.1097/00004872-200412000-00010. PMID: 15614022.

Ad Hoc protocol General population

While this paper concludes that "the PulsePen enables an easy and reliable evaluation of central arterial pressure and stiffness", a standard protocol was not used and only percentage differences are provided, with no defined pass/fail criteria.

Relevant Publications

Joly L, Perret-Guillaume C, Kearney-Schwartz A, Salvi P, Mandry D, Marie PY, Karcher G, Rossignol P, Zannad F, Benetos A. Pulse wave velocity assessment by external noninvasive devices and phase-contrast magnetic resonance imaging in the obese. Hypertension. 2009 Aug;54(2):421-426. Epub: 2009 Jun 8. doi: 10.1161/HYPERTENSIONAHA.109.133645. PMID: 19506096.

This study concludes that, for body mass index values ≤ 35 kg/m², PWV measured externally with a PulsePen reflect values obtained directly in the thoracic aorta, through MRI, validly.