MY01, a medtech company based in Montreal, has developed the Continuous Compartment Pressure Monitor, a sterile, single-use device to aid in the diagnosis of acute compartment syndrome. If undiagnosed and untreated, acute compartment syndrome, a condition caused by high pressure around muscles typically following an injury, can have significant consequences for patients. Long-term disability and amputation is too often the result.
At present, the condition is diagnosed using subjective measurements such as pain. These can be unreliable, and given the potential for serious consequences, often clinicians will err on the side of caution. However, this sometimes results in unnecessary surgical procedures.
To address this, MY01 has developed a device that helps clinicians to diagnose acute compartment syndrome without the guesswork. The Continuous Compartment Pressure Monitor recently received FDA clearance and provides digital pressure readings continuously for up to 18 hours. The monitor will transmit data to a smartphone app, and is strapped to the patient’s limb during the monitoring phase.
See a video about the device below.
Medgadget had the opportunity to speak with Charles Allan, CEO at MY01, about the device.
Conn Hastings, Medgadget: Please give us an overview of acute compartment syndrome and how it occurs.
Charles Allan, MY01: Acute Compartment Syndrome (ACS) is a true orthopedic emergency. Trauma is the most common cause of ACS. Compartment syndrome is a potentially devastating and relatively common complication of fractures about the knee and tibial shaft. Following trauma, swelling may build up causing an increase in muscle pressure leading to ACS. Rapid diagnosis followed by prompt surgical decompression via a fasciotomy is critical to achieving favorable patient outcomes. ACS can lead to muscle necrosis and even death if left untreated.
Medgadget: How common is the condition?
Charles Allan: In the US, it is estimated that there is a prevalence of 500,000 cases per year that could be at-risk of Compartment Syndrome.
Medgadget: How is acute compartment syndrome currently diagnosed? How is this suboptimal?
Charles Allan: ACS is currently diagnosed based on subjective and unreliable outcomes such as pain. Existing compartmental pressure sensors are inaccurate and inefficient to use. Far too often trauma patients sustain long-term disabilities and limb amputations because of late or missed diagnoses. Not only does this impose a significant yet overlooked economic burden on national healthcare systems, but also patients sustaining these unacceptable outcomes suffer a greatly reduced quality of life.
Missed diagnosis and treatment (late fasciotomy) can have catastrophic consequences for the patient with 5.4% of all cases leading to amputation. Amputations carry a lifetime cost of over $600,000 and significant medicolegal liability risk to the surgeon and hospital. An acute compartment syndrome lawsuit rules in favor of the patient 33–55% of the time with damages awarded for litigation averaging over $1,550,000.
To limit the risk of missed or late diagnosis, it is widely considered among physicians that performing early fasciotomy is critical to achieving the best possible outcomes. In general, performing unnecessary/prophylactic fasciotomy is better than missing a true case of compartment syndrome. Trauma cases may be overtreated with fasciotomy to avoid ACS. Furthermore, unnecessary/prophylactic fasciotomies are associated with poor outcomes when compared with patients who did not receive the procedure.
Medgadget: Why are early diagnosis and treatment important in acute compartment syndrome?
Charles Allan: The most important determinant of outcomes from acute compartment syndrome after injury is delay in diagnosis. Muscle necrosis may occur within 2 hours of injury in as many as 35% of patients with ACS. The difference between foot numbness (5.36 h) and foot drop (7.25 h) can be as little as 2 hours. The severity of muscle necrosis and nerve injury worsens with the delay in performing fasciotomy.
A surgical fasciotomy is the only effective treatment, offering an immediate decrease in compartment pressure by increasing the volume of the affected muscle through the release of the skin and muscle fascia. Nonetheless, fasciotomy carries its own risk and complications, including long hospital stay, surgical site infection, a need for further surgery for delayed wound closure, and an overall increased cost of care.
Liberal use of prophylactic fasciotomies leave patients with large scars that carry their own documented set of complications. On average, performing a fasciotomy on a tibia fracture patient will increase their length of stay by 8 days and triple their risk of surgical site infection to 25%. Surgical site infection is the third most costly type of healthcare-acquired infection (HAI) with an estimated added cost of $23,466 per case.
Medgadget: Please give us an overview of the MY01 Continuous Compartment Pressure Monitor. How does it work?
Charles Allan: The MY01 Continuous Compartment Pressure Monitor is sterile, single use and comes ready to use with minimal training, minimal effort. Only MY01 enables digital pressure readings continuously over time. The MY01 comes equipped with an intuitively designed introducing mechanism that provides both single point (for determining most at-risk compartment) as well as continuous measurements. MY01 can be used for up to 18 hours. Data are stored and displayed at the bedside via the accompanying patient worn monitor. MY01 has wireless capabilities enabling pressure data to be visualized for trend analysis through our accompanying mobile application. MY01 is the only device which enables these features to promote care team collaboration, ultimately improving patient care. In terms of size, the device is smaller and lighter than a smartphone and rests on the patient’s affected limb using a built-in adhesive strip.
Medgadget: What inspired MY01 to develop the technology?
Charles Allan: Although MY01 originated as a lab project at McGill University in 2015 under the guidance of Dr. Edward J. Harvey, the idea has now developed into a growth stage startup employing a team of 50+ scientists, engineers, and business developers (collectively holding 74+ degrees and hailing from 16 different countries). The entire team is now oriented around a common mission: to empower healthcare professionals with the ability to diagnose emergent medical conditions and improve patient outcomes.
We believe physician-patient engagement is key to effective healthcare. Physicians unfortunately spend about 2 hours doing computer work for every hour spent examining patients. In person appointments are often spent interacting with a computer screen for over 50% of the time. Physicians need tools that allow quantitative patient evaluation and integrate more easily in conventional workflow.
MY01, our first product, is only the tip of the iceberg. Long-term, our vision is to create a lineup of smart digital diagnostic tools capable of outputting real-time data accessible at the physician’s finger tips. Our team plans on building sensor based medical devices to tackle other trauma related diagnostic problems including Chronic Exertional Compartment Syndrome (CECS), Intra-Abdominal Hypertension (IAH), and Spinal Epidural Hematoma (SEH). Not only will these devices connect to a single cloud-based platform, but the platform can be used to derive real time insights, freeing physicians from data entry, and allowing them to ultimately focus on the thing that matters most – the patient.
Medgadget: Congratulations on the recent FDA approval of the device. Where is the device currently available and do you plan to expand the availability soon?
Charles Allan: MY01 recently launched our continuous compartment pressure monitor and the device is currently in use at several major hospitals across the United States. Near term, the team is ramping up our Sales & Marketing efforts and is investing heavily in research, clinical education, and distribution.
The MY01 Continuous Compartmental Pressure Monitor has also received its CE Mark and Health Canada Medical Device License. MY01 has a clinical and commercial presence in Canada, France, Germany, Switzerland, and Belgium. The reception from interested parties has been great. Healthcare professionals recognize and appreciate the value our product offers as an aid in the diagnosing Acute Compartment Syndrome.
We’re also excited about our confirmed in-person presence later this year at the Orthopaedic Trauma Association (OTA) Annual Meeting.
Link: MY01 company homepage…