by Compartment syndrome is a potentially serious condition that occurs when pressure within muscles builds to dangerous levels. It most often affects the limbs, especially the lower legs and forearms. The increased pressure prevents blood from flowing into and out of the affected area. If not treated quickly, it can cause serious and permanent damage to muscles, nerves, and sometimes even amputation may be required.
Traditional diagnosis of compartment syndrome relies on clinical examination which includes pain out of proportion to injury upon passive stretch of the muscles in the affected compartment as well as tense swell compartments palpable under the skin. However, subtle Compartment Syndrome Monitoring Devices can be missed using clinical exam alone.
Continuous Intracapsular Pressure Monitoring
To address the limitations of clinical diagnosis, devices have been developed to continuously monitor pressure within muscle compartments.One such device is the Stryker Intra-Compartmental Pressure Monitor (ICM+). The ICM+ features a disposable probe that is inserted through a small incision directly into the muscle compartment of interest. It then provides real-time pressure readings displayed on a Bluetooth-connected monitor. Having objective pressure data allows clinicians to more accurately diagnose compartment syndrome and closely follow the effects of treatment like fasciotomy. If the monitored pressure drops below 30mmHg after surgical decompression, additional surgery is unlikely needed. The ICM+ received FDA clearance in 2014 and has been used in over 150 hospitals worldwide.
Advancements in Ambulatory Monitoring
While the ICM+ allowed for closed monitoring, it still required the patient to remain immobilized near the monitoring device. More recently, ambulatory monitoring systems have been developed to allow greater patient mobility. The Replai Compartment Pressure Monitoring System(Replai CPM) incorporates wireless probes and a small wearable monitor. After probe insertion, the patient can be safely discharged with continuous remote monitoring by the clinical team via a web portal. Alerts are generated if pressures rise above customizable thresholds. This permits early detection of recurrent compartment syndrome after initial fasciotomy. It has helped reduce the need for additional surgery from 30-50% down to 5-10% compared to clinical exam alone. The Replai CPM gained FDA clearance in 2018.
Remote Intraoperative Monitoring
Advancements have now enabled remote monitoring even during surgery itself. The Stryker Synchronous obtained FDA clearance in late 2020 for use during fasciotomy or other orthopedic procedures requiring muscle retraction. It functions similar to the ICM+ but integrates with the Stryker Synergy surgical platform. This allows pressures to be visualized simultaneously on the surgical display screen along with endoscopic camera views. Surgeons can objectively assess the adequacy of decompression in real-time without having to turn attention away from the surgical field. Preliminary case series show it reduces operating times by 10-15 minutes on average. Plans are underway to expand indications and integrate the technology with other major surgical robotic/navigation platforms.
Global Impact and Compartment Syndrome Monitoring Devices
The introduction of compartment monitoring devices has been transformational for the management of compartment syndrome worldwide. Key global trends include:
– North America remains the largest market due to earlier FDA clearances and greater healthcare spending levels per capita. Over 90% of level 1 trauma centers in the US now use intracapsular pressure monitoring routinely.
– Europe follows closely behind with rapidly growing utilization, led by countries like the UK, Germany, and France. National healthcare systems are beginning to provide broader reimbursement which will further accelerate adoption rates.
– Asia Pacific is poised to become the fastest growing regional market longer term. China in particular is heavily investing in improving trauma care access and technology. Indian government initiatives also aim to make advanced monitoring more accessible for rural populations.
– The Middle East is seeing a wider push towards establishment of specialized orthopedic/trauma centers. This drives demand for new tools to optimize complex surgical outcomes. Saudi Arabia has emerged as an early adopter.
– Africa presents challenges but also opportunities, as innovative portable/wireless designs could play a role in resource-limited settings if pricing barriers are addressed. Partnerships with NGOs remain crucial.
The increasingly mobile, intraoperative, and multi-specialty nature of new compartment monitoring platforms will be instrumental for helping turn this lifesaving technology into standard of care on a global scale over the coming decade.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
About Author - Ravina Pandya
Ravina Pandya,a content writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemicals and materials, etc. With an MBA in E-commerce, she has expertise in SEO-optimized content that resonates with industry professionals. LinkedIn Profile
