Frequently Asked Questions (FAQs)

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.

There is no definitive pressure threshold as of yet. An AAOS guideline recommends various thresholds for Acute Compartment Syndrome, one to rule it out and one to pose a diagnosis.

• • Various groups have concluded that perfusion pressure was a better proxy than Intra-compartmental Pressure alone, ^1,2,3, as it corrected a patient’s blood pressure variability. 
  • McQueen et al. suggested a threshold for surgical release is a perfusion pressure <30 mmHg for over 2 hours, as documented in ⁴. 
  • AAOS guideline recognizes that a perfusion pressure >30mmHg is a good indication of the absence of ACS and that “The best evidence available suggests a role for repetitive [or continuous] compartment pressure monitoring as the most reliable adjuncts to diagnosis.” ⁴

1. McQueen, M. M. and C. M. Court-Brown (1996). “Compartment monitoring in tibial fractures. The pressure threshold for decompression.” J Bone Joint Surg Br 78(1): 99-104.
2. McQueen, M. M. and A. D. Duckworth (2014). “The diagnosis of acute compartment syndrome: a review.” Eur J Trauma Emerg Surg 40(5): 521-528.
3. Schmidt, A. H. (2017). “Acute compartment syndrome.” Injury 48 Suppl 1: S22-S25.
4. Osborn, Col. Patrick M. MD; Schmidt, Andrew H. MD. Management of Acute Compartment Syndrome. Journal of the American Academy of Orthopaedic Surgeons 28(3):p e108-e114, February 1, 2020. | DOI: 10.5435/JAAOS-D-19-00270

• 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.

*Data presented at the Orthopedic Trauma Association Annual Meeting, Seattle, 2023. (ClinicalTrials.gov ID NCT04012723)

NOTE: MY01 is not responsible for the diagnosis of the patient, as the device and app are not diagnostic tools. 

• No. 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).

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.