MY01, a Montreal-based medical technology company, has developed the Continuous Compartment Pressure Monitor, a sterile, single-use device for diagnosing acute compartment syndrome. If left undiagnosed and untreated, acute compartment syndrome, a condition caused by high pressure around the muscles usually after an injury, can have important consequences for patients. The result is too often long-term disability and amputation.
Currently, the disease is diagnosed through subjective measures such as pain. These can be unreliable and, given the potential for serious consequences, doctors will often err on the side of caution. However, it sometimes results in unnecessary surgical procedures.
To address this, MY01 has developed a device that allows doctors to diagnose acute compartment syndrome without assumptions. The Continuous Compartment Pressure Monitor has recently received FDA approval and provides digital pressure readings continuously for up to 18 hours. The monitor will transmit data to a smartphone application and link to the patient’s end during the monitoring phase.
Watch a video about the device below.
Medgadget He had a chance to talk to Charles Allan, CEO of MY01, about the device.
Conn Hastings, Medgadget: Give us an overview of acute compartment syndrome and how it occurs.
Charles Allan, MY01: Acute compartment syndrome (ACS) is a real orthopedic emergency. Trauma is the most common cause of ACS. Compartmental syndrome is a potentially devastating and relatively common complication of knee and tibial shaft fractures. After trauma, inflammation can build up and cause an increase in muscle pressure leading to ACS. Rapid diagnosis followed by rapid surgical decompression by fasciotomy is critical to achieving favorable patient outcomes. ACS can cause muscle necrosis and even death if left untreated.
Medgadget: How often is this disease?
Charles Allan: In the US, it is estimated that there is a prevalence of 500,000 cases per year that could be at risk for 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 results such as pain. Existing compartmental pressure sensors are inaccurate and inefficient. Too often traumatized patients maintain long-term disabilities and limb amputations due to late or missed diagnoses. This not only imposes a significant but ignored economic burden on national healthcare systems, but also patients who sustain these unacceptable outcomes suffer from a very 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 in excess of $ 600,000 and a significant risk of medical liability for the surgeon and hospital. A lawsuit for acute compartment syndrome regulates 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 late or lost diagnosis, it is widely considered among physicians that performing an early fasciotomy is critical to achieving the best possible outcomes. In general, performing an unnecessary / prophylactic fasciotomy is better than missing a real case of compartment syndrome. Trauma cases can be overtreated with fasciotomy to prevent ACS. In addition, unnecessary / prophylactic fasciotomies are associated with poor outcomes compared to patients who did not receive the procedure.
Medgadget: Why is early diagnosis and treatment important in acute compartment syndrome?
Charles Allan: The most important determinant of acute compartment syndrome outcomes after injury is delayed diagnosis. Muscle necrosis can occur 2 hours after injury in 35% of patients with ACS. The difference between numbness of the foot (5.36 h) and fall of the foot (7.25 h) can be as little as 2 hours. The severity of muscle necrosis and nerve injury worsens with the delay in performing the fasciotomy.
A surgical fasciotomy is the only effective treatment, which offers an immediate decrease in compartmental pressure by increasing the volume of the affected muscle by releasing the skin and muscle fascia. However, fasciotomy carries its own risk and complications, such as a long hospital stay, an infection at the surgical site, the need for new surgery to delay wound closure, and a general increase in cost. of attention.
Liberal use of prophylactic fasciotomies leaves patients with large scars carrying their own documented set of complications. On average, performing a fasciotomy on a patient with a tibia fracture will increase their stay by 8 days and triple the risk of infection of the surgical site by 25%. Surgical site infection is the third most expensive type of health-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 it works?
Charles Allan: The MY01 continuous compartment pressure monitor is sterile, disposable and ready for measurement with minimal training and minimal effort. Only MY01 allows accurate digital pressure readings continuously over time. The MY01 comes equipped with an intuitive design input mechanism that provides both a point (to determine the most risky compartment) and continuous measurements. MY01 can be used for up to 18 hours. The data is stored and displayed at the head of the bed using the monitor used by the accompanying patient. MY01 has wireless features that allow you to view pressure data to analyze trends through our attached mobile app. MY01 is the only device that allows these functions to promote the collaboration of the care team, ultimately improving patient care. In terms of size, the device is smaller and lighter than a smartphone and rests on the affected limbs of the patient using an integrated adhesive tape.
Medgadget: What inspired MY01 to develop the technology?
Charles Allan: Although MY01 originated as a lab project at McGill University in 2015 under the direction of Dr. Edward J. Harvey, the idea has now become a growing start-up that employs a team. of more than 50 scientists, engineers and business developers (which has 74) + degrees and from 16 different countries). Now the entire team is geared around a common mission: to train healthcare professionals with the ability to diagnose emerging medical conditions and improve patient outcomes.
We believe that physician-patient engagement is key to effective health care. Unfortunately, doctors spend about 2 hours making computers for every hour spent examining patients. Face-to-face appointments are often spent interacting with a computer screen for more than 50% of the time. Physicians need tools that allow for quantitative assessment of the patient and are more easily integrated into the conventional workflow.
MY01, our first product, is just the tip of the iceberg. In the long run, our vision is to create a line of intelligent digital diagnostic tools capable of publishing real-time data accessible at your doctor’s fingertips. Our team plans to build sensor-based medical devices to address other trauma-related diagnostic problems, such as Chronic Stress Compartment Syndrome (CECS), Intra-Abdominal Hypertension (AHI), and Spinal Epidural Hematoma (SEH). These devices will not only connect to a single cloud-based platform, but can be used to obtain real-time information, freeing physicians from data entry and ultimately allowing them to focus on what matters most. matters: the patient.
Medgadget: Congratulations on the recent FDA approval of the device. Where is the device currently available and do you plan to expand its availability soon?
Charles Allan: MY01 has recently launched our continuous compartment pressure monitor and the device is currently used in several major hospitals in the United States. In the short term, the team increases our sales and marketing efforts and invests heavily in research, clinical education and distribution.
The MY01 continuous compartmental pressure monitor has also received its CE medical device license and CE mark. MY01 has a clinical and commercial presence in Canada, France, Germany, Switzerland and Belgium. The reception from those interested has been fantastic. Healthcare professionals recognize and appreciate the value our product offers as an aid in the diagnosis of acute compartment syndrome.
We are also excited to have our presence confirmed in person later this year at the annual meeting of the Orthopedic Injury Association (OTA).
Link: Company Home MY01 …