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The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.

PADnet Xpress, like the PADnet 2.0 aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial/Dorsalis Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Artery Disease (PAD). Following each test PADnet Xpress provides documented results, including waveforms, as part of the final report, which may be viewed on the system display, in printed form, and/or digitaly saved. PADnet Xpress was designed, in response to consumer feedback, to perform a subset of tests, namely PAD screening, which the predicate PADnet 2.0 device is capable of in a smaller, more portable form factor. The design modifications did not alter the intended use and are modest departures from the existing, previously cleared technological characteristics of the PADnet 2.0. While the intended use is not altered, there are minor modifications for use to remove elements of the indication not associated with arterial pulse contour analysis, and segmental systolic blood pressure measurements, as well as to allow for home use by a trained operator. When performing an assessment, the clinician places a sensor and takes a measurement on each lower extremity. The sensor detects changes in arterial blood volume. This signal is digitized and sent to a computer via a wired connection, where it runs a proprietary software application calculates the result, which is based on the features of the volume plethysmographic signals from the Brachial, Anterior Tibial arterial distributions. The indications for use are almost identical to the PADnet 2.0, the predicate device, but PADnet Xpress has also been tested for compliance with IEC 60601-1-11 home use electrical safety standards and is indicated for use in that environment as well with no change to the safety or effectiveness of the device. The PADnet Xpress sensor used with the predicate, is made from Makrolon plastic.