Masimo’s PVI Technology Cleared for South Korean Market

South Korean regulators have cleared Masimo’s noninvasive Pleth Variability Index measurement for clinical use. The index is a measure of the dynamic changes in the perfusion index that occur during one or more respiratory cycles, the Irvine, Calif., firm said Thursday.

PVI technology is available with any Masimo SET or Rainbow Oximetry sensor, the company said.

A joint review by the Ministry of Food and Drug Safety and the health technology assessment body found PVI to be effective, noninvasive way to predict fluid responsiveness in mechanically ventilated patients, Masimo said.

According to the regulators, PVI has a higher accuracy of diagnosis than static indices like central venous pressure and pulmonary capillary wedge pressure. It is comparable to dynamic indices like cardiac output variability, pulse pressure variability, blood volume amplitude variability and systolic pressure variability.

Clinicians use fluid administration to improve hemodynamics before, during and after surgery, Masimo said. Assessment of fluid responsiveness is essential to guide fluid therapy. — Kellen Owings