Remote monitoring awarded Class IIa label with Level of Evidence A
Brussels, 4 July 2013 - Eucomed, the European Medical Technology Industry Association, welcomes the update to class IIa with level of evidence A for device-based remote monitoring in the ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy (CRT). Class IIa therapies are treatments which are found to be useful and effective. The updated class not only reflects research findings which conclude that remote monitoring could help patients at high risk for stroke, but also follows a recent consensus between joint European and American experts on the benefits of remote monitoring for patients with a CRT device.
The ESC guidelines represent the official position of the European Society of Cardiology (ESC) and are intended to assist healthcare providers in clinical decision-making. Level of evidence A is the highest level available for a therapy, requiring the most clinical evidence, and is awarded only when data has been derived from multiple randomized clinical trials or meta-analyses.
The new guidelines state: Device-based remote monitoring should be considered in order to provide earlier detection of clinical problems (e.g. ventricular tachyarrhythmias, atrial fibrillation) and other technical issues (e.g. lead fracture, insulation defect).
Prof Angelo Auricchio, Past President of the European Heart Rhythm Association (EHRA) and co-author of the new Guideline said, “The fact that the new Guideline recommends device-based remote monitoring of the patient and the implanted device is a reflection of the increasingly robust body of evidence. We expect this Guideline update to further enhance the acceptance of device-based remote monitoring and to overcome the significant differences in adoption of this technology that still exist across Europe.”
“The Guideline update is critically important for policy-makers and payers across Europe, as it will give them the long-awaited ‘blessing’ of the clinical evidence on remote care that was accumulated over the past years. This should bring patients, providers and manufacturers a step closer to the establishment of sustained funding solutions for this therapy innovation, as outlined in the EHRA /Eucomed joint White Paper on CIED Telemonitoring reimbursement,” said Markus Siebert, Chair of the Eucomed Telemonitoring Working Group.
In heart failure patients, the heart often beats out of sync. Cardiac resynchronization therapy resynchronizes the beating of the heart by pacing both lower chambers (ventricles) rather than just one (the right ventricle). Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Remote monitoring is one option for patients who have a CRT device (including pacemakers and implantable cardioverter defibrillators) and can be used to detect abnormal heart rhythms.
Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. Eucomed represents directly and indirectly 25,000 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 95% of this sector. The market size is estimated at roughly € 100 billion while around 8% of sales revenue is ploughed back into research and development. The industry employs more than 575,000 highly skilled workers. For more information visit www.eucomed.org.
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