ExoStat Medical's MicroTREND System Receives FDA Clearance for Real-Time Oral Tissue Perfusion Monitoring
核心洞察
ExoStat Medical (搜索)'s MicroTREND system (搜索), designed for real-time detection of tissue hypoperfusion via oral mucosa, has received FDA 510(k) clearance.
The MicroTREND system (搜索) utilizes an electro-conductance platform with a non-invasive sensor to measure pCO2, a marker for tissue hypoperfusion.
This technology offers early detection of microcirculatory issues, potentially improving outcomes in critical conditions like septic shock (搜索).
ExoStat Medical (搜索) has announced that its MicroTREND System (搜索) has received FDA 510(k) clearance. The MicroTREND system is designed for the early detection and monitoring of tissue hypoperfusion at the microcirculatory hemodynamic level, using the oral mucosa as a measurement site.
Technology and Functionality
The MicroTREND system (搜索) incorporates an electro-conductance platform with a disposable sensor. This sensor is placed non-invasively in the patient's oral mucosal tissue, a convenient and accessible location for measuring pCO2, which is a clinically proven marker for tissue hypoperfusion. The system provides real-time data, enabling physicians to assess and treat microcirculatory hypoperfusion, a life-threatening medical emergency.
Development and Research
ExoStat Medical (搜索) has been developing the MicroTREND system (搜索) since 2008, with initial clinical work dating back to the late 1990s at the Weil Institute of Critical Care Medicine (WICCM). Dr. Max Harry Weil, considered the Father of Critical Care Medicine, and his team focused on capturing and measuring microcirculatory perfusion data using oral tissue to measure gut perfusion. Their research highlighted the importance of oral tissue perfusion pCO2 data in identifying early symptoms of microcirculatory hypoperfusion.
Clinical Significance
Wanchun Tang MD, MCCM, FAHA, FNAI, professor and long-time President at WICCM and Senior Medical and Technical Advisor at ExoStat Medical (搜索), stated, "Knowing microcirculatory tissue perfusion status early in septic shock (搜索)’s predictable cascade will provide physicians with evidence-based data that could lead to better patient outcomes. Monitoring pCO2 data later in the resuscitative process will also aide the care providers in determining the most effective end-point of resuscitation which is also critical to better outcomes for gravely ill ICU patients."
Company Statement
"The 510(k) clearance of the MicroTREND marks an important commercial milestone for ExoStat, and we look forward to working with key strategic partners to advance the next steps of the journey to improve patient care," said Jim Hays, Chief Executive Officer of ExoStat.