Partnering of Camgenium and Cardiac Tech to bolster post-cardiac surgery outcomes through implementation of Pace-Protect system technology.
Pace-Protect Medical Device Set for Clinical Trials
The Pace-Protect medical device, a groundbreaking innovation designed to improve patient outcomes following open-heart surgery, is now ready for clinical trials. This device combines the functionalities of real-time cardiac monitoring, alert systems, and pacing into a coherent medical device tailored for postoperative care in cardiac surgery patients.
The Pace-Protect device, developed in partnership between Camgenium and Cardiac Tech, addresses a significant unmet need in the healthcare industry. Each year, approximately 1,500 serious adverse events (SAEs) are reported in the US alone due to the management of temporary pacemakers following open-heart surgery [1]. Pace-Protect aims to prevent these SAEs by providing real-time monitoring and alerts that can ultimately prevent complications.
At the heart of Pace-Protect's technology is its continuous cardiac monitoring and pacing capabilities. Similar to bioadhesive pacing leads, Pace-Protect offers stable, atraumatic implantation and can maintain pacing function for extended periods, at least 14 days [2]. This continuous monitoring allows for early detection of arrhythmias or conduction issues, enabling timely interventions that can reduce complications after surgery.
Pace-Protect also features real-time alerts. The device can detect abnormalities as they develop and notify clinical staff promptly, ensuring a rapid response, which is critical for patients recovering after open-heart procedures. Furthermore, Pace-Protect enhances temporary epicardial pacing, a common practice during open-heart surgery, by adding intelligent monitoring and alerting layers [3].
In addition, Pace-Protect offers support for personalized treatment. By continuously assessing cardiac data, the device can guide adjustments in pacing rates or other therapies, potentially improving outcomes such as heart failure management [4][5].
The Pace-Protect prototype, which uses Soft Silicon mesh network technology, is now moving forward towards clinical testing. Soft Silicon is a highly sophisticated mesh architecture for communications that uses Bluetooth Low Energy (BLE) and Wi-Fi, cellular, Near Field Communication (NFC) and Long Range (LoRa) [6]. Camgenium has integrated its proprietary Soft Silicon medical device grade two-way device communications technology for data transmission into the Pace-Protect prototype.
This marks a significant milestone for Pace-Protect, as it will be the first device using a Soft Silicon mesh network to be deployed in a clinical environment. The clinical trials for Pace-Protect will provide valuable data on its efficacy and safety in a real-world setting, offering the potential for improved patient outcomes following open-heart surgery by minimizing adverse events related to temporary pacemakers.
Camgenium and Cardiac Tech have agreed to continue their collaboration in bringing the Pace-Protect prototype to patients. The successful completion of these clinical trials will bring us one step closer to deploying Pace-Protect to patients, potentially revolutionizing the way temporary pacemakers are managed following open-heart surgery.
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- The Pace-Protect device, designed to improve outcomes following open-heart surgery and prevent serious adverse events (SAEs) in cardiac surgery patients, is now set for clinical trials.
- Pace-Protect's technology, which includes continuous cardiac monitoring, real-time alerts, and support for personalized treatment, is poised to revolutionize the management of temporary pacemakers, particularly in the realm of health-and-wellness and medical-conditions related to cardiovascular health.
- The partnership between Camgenium and Cardiac Tech aims to gather valuable data during clinical trials, utilizing advanced technology like Soft Silicon mesh network, in order to better understand and enhance the device's efficacy and safety for the betterment of patient health and science.
