NEWS RELEASE: Camgenium and Cardiac Tech Partner to Improve Patient Outcomes Post-Cardiac Surgery with Pace-Protect System
– Camgenium and Cardiac Tech have developed an innovative solution to adverse events caused by current temporary pacing methods used in intensive care wards –
– Pace-Protect will be the first medical device using a Soft Silicon™ mesh network to be deployed in a clinical environment –
[Image courtesy of Camgenium]
Pace-Protect is a safety device designed to monitor all aspects of temporary pacing and report acute changes immediately to clinicians via a cloud-based platform and app. The communications electronics used in the physical system, as well as the cloud-based platform and app have been developed by Camgenium.
Camgenium has integrated its proprietary Soft Silicon™ medical device grade two-way device communications technology for data transmission into the Pace-Protect prototype. Soft Silicon™ is a highly sophisticated mesh architecture for communications using BLE and Wi-Fi, cellular, NFC and LORA. It establishes world class data security for patient confidentiality and high resilience to ensure individual Pace-Protects never loses contact with the cloud, ensuring safety even when a patient is moved around the hospital. Soft Silicon™ also allows real-time patient electrogram (EGM) data to be transmitted to the clinical team at high data rates in emergencies. Pace-Protect will be the first device using a Soft Silicon™ mesh network to be deployed in a clinical environment.
“Following open heart surgery, patients often experience rhythm disturbances which can lead to serious complications,” said Will Simpson, CEO at Cardiac Tech. “We wanted to develop a pioneering solution which enables medical professionals working in high pressure environments to be alerted of any issues immediately, bringing help to the patient before an adverse event occurs. Partnering with Camgenium is helping to bring our vision to life.”
Temporary pacemakers are currently programmed manually according to the patient’s requirements but these parameters frequently change as the heart’s conduction system recovers.[i] These changes often go unnoticed, leading the patient’s own heart to ‘conflict’ with the impulses from the external pacemaker.[ii] Research indicates that there are roughly 1,500 serious adverse events (SAE’s) reported each year following open-heart surgery attributable to the management of temporary pacemakers in the US alone.[iii] The Pace-Protect system addresses this unmet need for safer temporary pacemakers by providing real-time monitoring and alerts that can ultimately prevent SAEs.
“We worked incredibly closely with the team at Cardiac Tech to fully understand the needs of the patient and the clinician in the hospital,” said Dr Philip Gaffney OBE, CEO at Camgenium. “This enabled us to develop a user interface and user workflow that was optimised for clinical use in the hospital and met the regulated and other NHS standards for user interfaces within the highly demanding class II medical device environment.”
Camgenium and Cardiac Tech are committed to working together to bring this novel technology to patients. The functioning Pace-Protect prototype, which has been developed to ISO 13485 and IEC 62304 Class IIa standards, is now planned to go into clinical trials.
About Camgenium
Camgenium specialises in the rapid development and deployment of regulatory compliant medical AI models, software and connected hardware medical devices. Established in 2007, Camgenium has a reputation for regulatory excellence, working to standards including ISO 13485, ISO 27001, GxP and the NHS Data Security & Protection Toolkit.
Camgenium has developed market-leading AI solutions derived from >100m global healthcare records as well as software products that have been deployed worldwide to tens of thousands of patients. Camgenium is certified by the NHS to access national data sets for development of AI and ML algorithms.
The company has developed proprietary technology to accelerate development and has world-class medical hosting facilities in the UK, also servicing Europe, USA and Canada. It also has operations in New Zealand.
Cambridge based Camgenium has a client-centric approach, offering a complete service model from initial product concept through development, production, and deployment to decommissioning. The company can take regulatory responsibility for the whole product lifecycle and can deploy globally.
Camgenium has assembled a best-in-class expert team of engineers, scientists and mathematicians. The team’s commitment to engineering excellence is demonstrated by its pro bono work teaching medical device design to students at Cambridge University Engineering Department, educating the next generation of medical device engineers.
Camgenium is the trading name of L2S2 Ltd.
To discover more about Camgenium, please visit www.camgenium.com
About Cardiac Tech
Cardiac Tech is an early-stage medical device company that is developing novel technology in the field of temporary pacing with the goal of improving patient outcomes and reducing mortality post-surgery.
Many people are unaware that after open heart surgery, patients often experience rhythm disturbances which can lead to serious complications. To counter this, patients are typically fitted with a temporary pacing system to regulate their heart and ensure normal cardiac output is maintained during recovery.
Temporary pacemakers are relatively unsophisticated devices when compared to permanent pacing systems as they are unable to monitor their own thresholds, timings, or patient parameters. Meanwhile, the pacing wires that are relied upon to deliver therapy can be displaced through movement or be subject to contact degeneration as the surrounding tissue changes.
This instability, coupled with infrequent checks, can lead to a failure to identify acute and sudden changes in pacing function or patient underlying rhythm. As a result, cardiac output may be affected, leading to an extended and costly ITU stay.
Other more serious consequences of a failure to recognise changes in pacing parameters can result in pacing-induced cardiac arrest and even death.
Cardiac Tech has received venture and grant backing to develop its patented intracardiac signal monitoring technology and software algorithms, and is working with Camgenium to deploy its technology in the highly-regulated clinical environment.
To discover more about Cardiac Tech Ltd., please visit www.cardiac-tech.com
[i] Bhaskar SB. Manual of ICU procedures. Section 2: Vascular and Cardiac Procedures. Indian J Anaesth. 2016;60(11):362-363. doi:10.4103/0019-5049.193716
[ii] Chemello D, Subramanian A, Kumaraswamy N. Cardiac arrest caused by undersensing of a temporary epicardial pacemaker. Can J Cardiol. 2010;26(1):e13-e14. doi:10.1016/s0828-282x(10)70334-2
[iii] What is temporary pacing? Cardiac Tech. Available at: https://cardiac-tech.com/background/. Last accessed: 30 April 2025
The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
