10 September 2018

Cardiograph T-shirt

Servier's WeHealth Division at the Congress European Society of Cardiology-2018

Digital portable device CARDIOSKIN changes the idea of long-term cardiac monitoring

Paris, France. The WeHealth Digital Solutions division of the Servier Group of Companies has announced the launch of a CARDIOSKIN device – a 15-channel electrocardiogram (ECG) recording device for outpatient use. The company presented a new solution at the annual Congress of the European Society of Cardiology (ESC), which was held in Munich (Germany) from August 25 to 29.

cardioskin.jpgCARDIOSKIN is an "intelligent tissue" integrated into a T–shirt that is capable of measuring various parameters of the electrical activity of the heart and detecting pathological changes in situations requiring long-term monitoring. ECG data can be transmitted in real time, which can significantly speed up the process of diagnosis and clinical decision-making. Using a mobile application, the patient can record the moment of the onset of symptoms, and the cardiologist can compare this data with the information received from the sensors on the T-shirt. Sophisticated software integrated into the cloud platform allows you to analyze all the data obtained, which is of significant value to the doctor and the patient.

In modern medical practice, there is a problem of undiagnosed or misdiagnosed arrhythmia. For example, fainting in many patients may be potentially associated with severe cardiac arrhythmias, which are either rarely diagnosed, or, based on clinical manifestations, are mistaken for epilepsy attacks due to the difficulty of registering paroxysmal rhythm disturbances. Atrial fibrillation – the most common heart rhythm disorder – is often episodic and difficult to diagnose, but it entails a significant risk of stroke. In addition, short-term paroxysms of atrial fibrillation, which cannot be detected in the absence of long-term ECG monitoring, can be observed in patients with stroke of unknown etiology. Such a standard method as daily ECG monitoring by Holter can only be used for several days, and a large number of wires connected to the chest and an ECG recording device often cause discomfort to patients. All these factors indicate a high need for a simpler and more convenient way of long-term ECG monitoring.

Due to the increased duration of ECG monitoring and the convenience of this method, the digital portable CARDIOSKIN device helps to detect cardiovascular diseases (for example, arrhythmias, ischemic changes). Such conditions may be episodic and not manifest themselves. With the help of this device, doctors can develop individual therapy based on the patient's condition and taking into account his needs.

"The CARDIOSKIN device makes it possible to optimize the daily work of doctors. I have high hopes for the development of innovative solutions that improve patient monitoring methods," said Dr. David Gez, Director of Servier's WeHealth division.

Digital solutions include information and communication technologies for treatment, research, training of medical specialists, monitoring the course of diseases and monitoring the health status of the population. Mobile apps and devices are increasingly being used in various aspects of our daily lives, offering new ways to solve society's problems. Modern technologies can change medicine and healthcare.

This year, the Digital Medicine Era section became an integral part of the event in Munich and served as a platform for 15 scientific sessions related to all aspects of this topic during the Congress of the European Society of Cardiology – 2018.

About electrocardiograms (ECG) and cardiovascular diseases

Often, the diagnosis of paroxysmal cardiac arrhythmias is not an easy task, since they can last only a few seconds or minutes and rarely occur. Today's approach to diagnosis includes systems such as daily ECG monitoring by Holter, in which several ECG electrodes are fixed on the chest on one side, and on the other side are attached to a small block that needs to be worn on the body. However, such options are limited to a few days of recording, so they do not provide enough information to avoid missing a short-term episode of arrhythmia. There are implantable heart monitors, but they require an implantation procedure, and there are often problems with the effect of "noise guidance" on the ECG signal. In addition, these systems are not convenient for all patients and are often associated with a negative experience of use. As is known, the diagnostic capacity of 24-hour Holter ECG monitoring ranges from 15% to 39%, and the first recorded paroxysmal arrhythmia occurs on average after 7.7 days of follow-up, which significantly exceeds the patient's ability to use daily Holter ECG monitoring. There is an urgent need for a long-term, patient-friendly and variable method of heart rate monitoring. Currently, cardiovascular diseases (CVD) are the leading cause of death worldwide. It is estimated that 17.7 million people died from CVD in 2015, accounting for 31% of all deaths. Among these deaths, it is estimated that 7.4 million were associated with coronary heart disease and 6.7 million were caused by stroke. In 2010, an estimated 33.5 million patients with atrial fibrillation were registered worldwide.

About the CARDIOSKIN device

CARDIOSKIN is an outpatient ECG device with 15 leads for long-term monitoring. It was developed in collaboration with the French startup company "Bioserentity". The use of 12 sensors makes it possible to detect heart rhythm disturbances in real time and send the received data to the attending physicians. Thus, information for diagnosis can be collected remotely, on an outpatient basis. CARDIOSKIN is a non–invasive medical device that has received CE marking and approval from the US Food and Drug Administration (FDA) on Form 510 [k], which allows ECG monitoring and outpatient diagnostics for a period of several days to several weeks. This is a simple system consisting of 15 wires embedded in a special fabric and connected to a data acquisition module that registers an ECG signal. This module performs analog-to-digital signal conversion and sends them wirelessly to the cloud, providing both secure data storage and remote access for the attending physician. CARDIOSKIN combines during the entire observation period with fairly good patient tolerance, and a large number of electrodes reduces the number of artifacts ("noises"), which at the same time allows for a more accurate and timely diagnosis.

About Servier

Servier is an international pharmaceutical company managed by a non–profit foundation, the company's head office is located in Suresnes, France. The company is represented in 148 countries

on 5 continents and has more than 21,600 employees. Servier's annual turnover in 2017 amounted to 4,152 billion euros. The company's high growth rates are due to the constant development and search for innovations in five key areas: diabetes mellitus, cardiovascular, oncological, immuno-inflammatory and neurodegenerative diseases, as well as activities to create high–quality generics.

Additional information is available on the company's website.

About Servier's WeHealth Division

Created in November 2016, Servier Group's WeHealth Digital Solutions division aims to improve the daily lives of patients and medical professionals through the use of digital technologies. Servier's WeHealth offers innovative digital and related solutions and services. This approach, based on the use of the data obtained, is used for the best individual monitoring of patients, as well as prevention and prediction of further development of the disease. Using an open innovative approach, Servier's WeHealth division finds the most promising start-up companies in the field of e-health in France and other countries to jointly develop solutions. Thus, Servier's WeHealth division participates in the creation of a partner ecosystem, the purpose of which is to accelerate the development, production and distribution of innovative solutions and ensure their accessibility to the largest number of people. Additional information is available on the WeHealth website.

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