Holter systems for electrocardiogram (ECG) monitoring are usually employed for arrhythmia disease detection. Non-symptomatic patients are difficult to diagnose. Glanum has developed a user-friendly patch containing an ECG monitor which records data about a patient’s heart. Their plan, supported by EU funding under the HeartService project, is for this timely data be sent to their virtual diagnostic centre (Glanum Diagnostics), already up and running, for review by cardiologists. Glanum is currently waiting for CE certification for the patch, after which they have secured funding to manufacture it (at a small scale), and pilot it with selected physicians. Following this the team intends to market it to GPs, diagnostic centres and hospitals in the Netherlands. EU support has specifically enabled the team to develop a wider roll-out plan across Europe.
Improving data capture and diagnostics
The current practice for ECG monitoring using Holter devices is not sustainable, given the rapid growth in the number of patients suffering from chronic cardiovascular diseases. Firstly, the procedure requires multiple visits to a medical centre for the Holter system to be attached and removed, which is labour-intensive. Secondly, the analysis of the ECG data by specialists delays the time between measurement and diagnosis. Furthermore, patients can face long waits for monitors to become available, as well as waiting to be seen by specialists. The Glanum solution provides a viable alternative. The patch contains three (printed) electrodes on a sensor processing unit (an AI-enhanced integrated circuit) base. The electronic module which captures, processes and stores the ECG signal within its internal memory is fully integrated into the patch. This highly sensitive monitoring arrangement can provide reliable ECG data for up to a week, and unlike the Holter system, patients are not limited in their movements (by the Holter wires). It is also small, thin and waterproof. At the completion of monitoring, patients remove the patch and send it to Glanum Diagnostics for analysis. Together with medical specialists, Glanum Medical has launched a diagnostic service centre for the analysis of ECG data. With this service, medical doctors can outsource the ECG analysis, reducing the diagnosis time. Testing took place with an ECG simulator connected to the patch, along with live testing where patches were attached to the body of 25 volunteers. In addition, Electromagnetic Compatibility, Electrostatic Discharge and IPX7 tests (protection provided by casings against intrusion, dust, accidental contact and water) were performed. “The patch performs as expected and can be used to capture ECG,” says Inge Sieben, project coordinator and CEO of Glanum Medical.
Designed to meet a real need
According to the WHO, cardiovascular disease accounts for 31 % of all global deaths, some 17.9 million people. In Europe, it is estimated to cause 45 % of all deaths. The WHO has also stated that cardiovascular disease death rates will decrease if detected early. “We concentrated on meeting the real needs of our market from the start. We interviewed GPs and cardiologists and learned that, as well as the patch, GPs needed the diagnostic service centre, while cardiologists needed patch functionalities that surpass conventional Holter systems,” says Sieben. After receiving the CE mark for their Holter patch, the team aim to start production before scaling up their ECG service in the Netherlands. In 2021, they plan to roll out the Holter ECG monitoring service and patch abroad, focusing initially on Germany and Sweden.
HeartService, Holter system, ECG, electrocardiogram, heart, sensor, AI, patch, cardiologists, rhythm, valves, coronary arteries, pump function