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The SensiLase® PAD-IQ provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

The Sensit.ase® PAD-IQ (PAD-IQ) Skin Perfusion Pressure System provides measurements of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR). Both measurements may be clinically applied to assess perfusion. Both the SPP and PVR measurements are features of the predicate PAD3000 device. The same methods are applied for measurement of SPP and PVR in the PAD-IQ as are applied in the predicate PAD3000. The SPP measurement relies on the creation of reactive hyperemia. Reactive hyperemia is the transient increase in blood flow that occurs following a brief period of ischemia. The SPP measurement is performed by applying a pressure cull capable of occluding skin blood flow (perfusion) to a peripheral location (arm, leg, toe. finger, etc.). The pressure cuff is inflated until the skin perfusion, as detected by a laser Doppler signal measured underneath the cuff, is determined to be near zero or significantly reduced. The pressure is released until an increase in skin perfusion is determined. The cuff pressure when the skin perfusion increases is the SPP is a test used to evaluate peripheral microcirculation. The SPP neasurement can be useful in identifying patients with peripheral arterial disease (PAD), other alterations in microcirculation, and to aid in the determination of optimum clinical treatment. The PVR test measures and displays a waveform representing variations in the volume of blood passing through a limb during each cardiac cycle. The PVR test is fully automated and uses a partially inflated pressure cuff to apply slight pressure to the limb. The impact of blood passing through the limb is transferred to the pressure cuff where it is measured as small changes in cuff pressure. The changes are displayed as a PVR waveform. The PVR waveform can be used as a measure of functional severity of occlusive disease and as un objective for later comparisons. The PVR test is sometimes referred to as air plethysmography or volume plethysmography. The clinical application and interpretation of the SPP measurements and interpretation of the PVR Waveform is the same as the predicate PAD3000. The differences between the predicate PAD3000 and the PAD-1Q device are summarized as: - Change from one channel of measurement to two channels of measurement, . - Modifying device format for increased portability within a clinical environment of use. . - Inclusion of operation by battery. .