FDA Clears MicroTREND for Tissue Hypoperfusion Insights

ExoStat Medical recently secured 510(k) clearance from the US Food and Drug Administration (FDA) for its MicroTREND system, a unique, non-invasive device designed to detect early signs of tissue hypoperfusion — a critical condition where tissues receive inadequate blood flow.

Tissue hypoperfusion often occurs during shock, a critical state where tissues receive insufficient oxygen, usually alongside declining blood pressure. Shock can result from heart failure, blood loss or blood flow issues and is frequently seen in emergency and intensive care unit (ICU) settings. Devices like MicroTREND provide real-time data, allowing faster intervention to prevent organ damage, improve survival rates and support recovery in high-risk patients.

Often associated with critical conditions like septic shock, hypoperfusion requires rapid intervention to prevent life-threatening consequences. An early indicator is an elevated partial pressure of carbon dioxide (pCO₂) level in tissue, signaling that cells are not receiving sufficient oxygen.

Monitoring these levels in real-time enables clinicians to identify at-risk patients sooner, allowing for targeted interventions that could improve survival rates and reduce long-term complications in intensive care settings.

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The MicroTREND system measures pCO₂ levels in the oral mucosal tissue, a sensitive area that provides real-time insights into microcirculatory blood flow. This data-driven approach empowers healthcare providers to respond swiftly, addressing hypoperfusion before it escalates into severe complications.

The MicroTREND system utilizes an advanced sensor that monitors and reports tissue pCO₂ levels every two minutes for up to four hours at a time, providing continuous data on tissue perfusion status. This frequent monitoring allows for timely detection of hypoperfusion, facilitating prompt medical response.

The device’s non-invasive design ensures patient comfort and ease of use in various clinical settings.

According to Jim Hays, president and CEO of ExoStat Medical, tissue hypoperfusion, when left undetected, can lead to severe outcomes such as ischemia, multiple organ dysfunction syndrome (MODS) and even death.

The MicroTREND system reflects insights from Dr. Max Harry Weil, a pioneer in critical care medicine who highlighted the significance of monitoring tissue perfusion to assess shock. His work laid foundational principles that underscore the importance of detecting circulatory issues early to prevent severe complications.

Today, ExoStat aims to collaborate with healthcare leaders to integrate this tool into critical care, advancing patient outcomes through innovative, data-driven early detection.