News | April 03, 2008

Masimo PVI Cleared for Market in Japan

April 4, 2008 – Masimo said yesterday the Japanese Ministry of Health, Labor and Welfare (MHLW) approval of its PVI measurement for the Japanese market.

The PVI is an index automatically derived from the Masimo plethysmographic waveform, which has been demonstrated to noninvasively assess fluid responsiveness in mechanically ventilated patients and can help clinicians assess if a patient’s cardiac function is compromised. PVI may help clinicians and emergency professionals to determine if a patient is dehydrated or over-hydrated, enabling more accurate fluid administration decisions. The PVI value is continuously displayed on Masimo Rainbow SET Pulse CO-Oximeters. The Rainbow SET technology delivers multiple physiologic measurements that previously required invasive blood tests, including total hemoglobin (SpHb) and oxygen content (SpOC) (both pending FDA and other regulatory clearances), carboxyhemoglobin (SpCO), methemoglobin (SpMet), PVI, oxyhemoglobin (SpO2), perfusion index and pulse rate.

During surgery and post-operatively, the immediate identification and rapid intervention of patients who are most likely to respond to fluid administration (fluid responders) can enable organ preservation, while recognizing patients unlikely to respond to fluid administration (fluid non-responders) can prevent pulmonary edema. Clinical studies have shown that current static methods for assessing fluid responsiveness, including clinical examination, arterial blood pressure, heart rate and central venous and pulmonary artery occlusion pressure, are poor predictors of fluid responsiveness.
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