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Frequently Asked Questions
Can the MY01 Continuous Compartment Pressure Monitor be used post-operatively?
Yes. The device can be used post-operatively as an aid in the diagnosis of Compartment Syndrome.
• The device has been used post-op by care teams to monitor the risk of ACS in patients who have been given nerve blocks for pain relief – eliminating one of the indicators currently used in clinical diagnosis of ACS.
• In general, it’s observed that at a given time the compartmental pressure is higher in postoperative cases. However, in normal cases, the pressure does not trend up or change as quickly as with ACS cases. The pressure actually decreases gradually, four to five hours postoperatively.
How accurate is your device?
• In multi-center, prospective studies, the MY01 device aided in an accurate diagnosis up to five hours earlier than the standard of care 100%* of the time, with no missed cases of ACS and no false positives. The device has demonstrated >99% sensitivity and specificity.
• MY01 device is an aid to diagnosis. Ultimately, healthcare professionals must always make the diagnosis in conjunction with clinical signs.
*As presented at the Clinical Orthopaedic Society and Military Health Sciences Research Society 2022 Annual Meetings.
NOTE: MY01 is not responsible for the diagnosis of the patient, as the device and app are not diagnostic tools.
How is our device different to others?
• The MY01 device is not a fluid-based pressure monitoring tool. It is a single-use, self-calibrating tool that is truly continuous in its pressure monitoring.
• MY01 device uses a microelectromechanical (MEMS) sensor that can be inserted directly in the most at-risk compartment.
• The MY01 app connects to the MY01 device via Bluetooth and displays pressure values in real time. This allows for smoother care team collaboration and the visualization of pressure trends over time.
• In a usability study conducted with the device, users mentioned ease of use being an improvement over incumbent technology (single-use, pre-assembled, sterile, introduction method).
What do “best practices” for this device look like throughout patient care?
The MY01 Continuous Compartmental Pressure Monitor should be used alongside the current standard of care.
• Physical examination alone has limited sensitivity and specificity for ACS. Serial examinations are important in patients at risk.
• Whenever possible, pressure measurements should be obtained by the surgeon who will perform the fasciotomy. Pressure measurements can be obtained with the MY01 Continuous Compartmental Pressure Monitor.