Collaboration between Camgenium and Cardiac Tech to enhance post-surgery cardiac care through the integration of a pace-protect system
In a significant breakthrough for cardiac care, a new medical device called Pace-Protect is set to enhance patient outcomes following open-heart surgery. This innovative device, developed by Camgenium and Cardiac Tech, offers real-time cardiac monitoring and pacing with a novel bioadhesive pacing lead.
The bioadhesive pacing lead provides stable, atraumatic epicardial integration, enabling continuous monitoring and effective ventricular pacing. This leads to a reduced risk of postoperative arrhythmias such as complete heart block, thereby improving safety and recovery. The lead maintains stable pacing thresholds over at least two weeks post-implantation, a critical period in the vulnerable postoperative phase.
Compared to traditional commercial pacing leads, the Pace-Protect lead demonstrates superior performance with lower stimulation thresholds and longer-term capture reliability. This allows clinicians to receive real-time alerts and intervene promptly if arrhythmias or conduction problems arise.
External pacemakers such as the OSYPKA PACE 300® integrate with temporary pacing leads to provide adjustable, multi-chamber pacing support, optimizing left ventricular hemodynamics. These devices support flexible pacing modes (single, dual, triple chamber) and can deliver precise pacing amplitudes and rates, tailored to patient needs immediately after surgery.
Together, these components form a system that continuously monitors heart rhythm post-surgery and offers pacing therapy to prevent adverse cardiac events. The real-time monitoring and alerting capability help improve patient outcomes by enabling earlier detection and management of arrhythmias that can complicate recovery after open-heart surgery.
The Pace-Protect device is designed to meet the regulated and other NHS standards for user interfaces within the highly demanding class II medical device environment. It is also committed to be brought to patients, with the prototype planned for clinical trials.
The functioning Pace-Protect prototype is the first device to use a Soft Silicon mesh network to be deployed in a clinical environment. Soft Silicon is a highly sophisticated mesh architecture for communications using BLE and Wi-Fi, cellular, NFC, and LORA, providing world-class data security and high resilience. Camgenium has integrated its proprietary Soft Silicon medical device grade two-way device communications technology for data transmission into the Pace-Protect prototype.
In addition, 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. It addresses an unmet need for safer temporary pacemakers by providing real-time monitoring and alerts that can ultimately prevent serious adverse events (SAEs) related to the management of temporary pacemakers.
Research indicates that roughly 1,500 SAEs are reported each year following open-heart surgery attributable to the management of temporary pacemakers in the US alone. By addressing this issue, Pace-Protect has the potential to significantly improve patient safety and outcomes in the field of cardiac care.
Sources: [1] [Journal Article 1] [2] [Journal Article 2] [3] [Journal Article 3]
- Clinical trials for the Pace-Protect device, a new medical device designed to enhance patient outcomes following open-heart surgery, are planned to be brought to patients, as it is designed to meet the regulated standards for medical devices.
- Pace-Protect, integrated with digital health technologies like Soft Silicon mesh network, offers real-time monitoring and alerts for cardiovascular health, thereby addressing an unmet need for safer temporary pacemakers and reducing the risk of serious adverse events (SAEs) related to their management.
- In the rapidly advancing digital health landscape, Pace-Protect, with its innovative bioadhesive pacing lead and real-time monitoring capabilities, contributes significantly to science and medical-conditions management, focusing on health-and-wellness, particularly cardiovascular health and postoperative patient recovery.
