Stockholm 6 June 2018
Zenicor Medical Systems AB (publ) has been selected as sole supplier for a screening programme in the UK for atrial fibrillation. The screening programme is the world’s largest randomised controlled trial to discover whether screening systematically for atrial fibrillation, a heart condition responsible for one in ten strokes, and offering optimal treatment reduces the incidence of stroke, premature death and other health risks associated with atrial fibrillation. In total over 300 general practices across England will participate.
"It is very pleasing that Zenicor has been chosen in competition with all the international competitors in the market. The project consolidates Zenicor-ECG as the primary method of screening for atrial fibrillation," said Zenicor's CEO Mats Palerius.
The research, led by the University of Cambridge, will involve 120,000 patients aged over 65 in 300 general practices within NHS across England and is financed by NIHR, National Institute for Health Research. Patients in 100 practices will undergo screening, and those in 200 practices will not. Patients will be loaned a handheld ECG device, provided by Zenicor, to measure a (single lead) ECG twice a day at home for two weeks. People who are found to have atrial fibrillation by the screening programme will be offered treatment with anticoagulant drugs to reduce their risk of stroke and heart attack. Both sets of patients will be followed up for five years to see whether screening and treatment leads to fewer strokes, heart attacks and deaths. The screening programme is expected to start during the summer of 2018 and last until 2021.
Lead investigator Professor Jonathan Mant, Professor of Primary Care Research and Head of the Primary Care Unit at the University of Cambridge said:
“We needed a system that is simple to use that is able to record an ECG of high diagnostic quality and that can manage large amounts of ECGs and patients. Zenicor is one of few systems fulfilling these requirements. This, in combination with the knowledge that this system has already successfully been used in large studies made Zenicor an obvious choice for our research.”
Co-applicant Professor Richard Hobbs, Professor of Primary Care Health Sciences at the University of Oxford and Director of the NIHR School for Primary Care Research, said:
“There’s currently not any evidence on whether systematic screening for atrial fibrillation works, so the National Screening Committee is not able to recommend it. Whether or not this research shows that screening is effective and cost effective, it will be a landmark trial that will affect UK screening guidance and guidance elsewhere around the world.”
About Atrial fibrillation (AF)
Atrial fibrillation is the most common disturbance of the heart rhythm, characterised by an irregular pulse. It affects up to 10 in 100 people over the age of 65, a considerable proportion of whom do not know they have the condition. Atrial fibrillation may not be associated with any symptoms, but is linked to increased risk of stroke, heart attack, dementia and premature death. About 10% of strokes happen in people unaware that they have atrial fibrillation. However, therapy with medication (anticoagulation) is highly effective at reducing the risk.
At present, some GPs look for atrial fibrillation opportunistically by using a diagnostic device such as a hand-held electrocardiogram (ECG) or simply take the pulse of patients who could be visiting for any reason. However, this is not done in a systematic way, and only in some general practices. One problem with the current approach is that some people do not have atrial fibrillation all the time but go into and out of an irregular heart rhythm.
For more information on the screening programme, read the pressrelease from University of Cambridge that was published on the 16th of May 2018: http://www.phpc.cam.ac.uk/pcu/nihr-awards-3m-for-new-research-to-investigate-screening-to-prevent-one-in-ten-strokes/
About Zenicor and Zenicor-ECG
Zenicor Medical Systems AB is a Swedish medical technology company that was founded in 2003 and has since then grown to become one of the leading medtech companies in Europe in the fields of early diagnosis of arrhythmias and stroke prevention for health care, and is today being used in over 400 clinics in ten countries in Europe. The effectiveness of the system has been proven in a large number of internationally acclaimed research studies that have been published in medical science journals. These studies have all shown that Zenicor-ECG, in combination with cost-effectiveness and ease of use, has a superior diagnostic accuracy compared to traditional methods.
For more information, please contact:
Mats Palerius, CEO, Zenicor Medical Systems AB,
Tel: +46 70 561 55 64
Hi-res pictures of Zenicor-ECG are available for download at: https://zenicor.com/press-material/