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news.Biotronik, a cardiovascular medical device company, has announced new positive data which showed that remote monitoring of its implantable cardioverter defibrillators is a safe and effective alternative to conventional in-office follow-up care, which helps reduce the burden on capacity-constrained cardiac centers.
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The Trust clinical study used Biotronik Home Monitoring, an automatic, wireless system that performs daily telemetric surveillance of the patient and the technical status of the implanted device.
In comparison with the control group of patients enrolled in conventional in-office follow up, clinical trial data from Trust show that remote monitoring reduces the number of in-office follow-up visits while maintaining patient safety, leads to earlier detection of arrhythmic events and drives efficient use of clinic time.
The Trust clinical study tested the hypothesis that remote monitoring was safe and effective for implantable cardioverter defibrillators (ICD) follow up for more than one year in a prospective, randomized controlled clinical trial.
The multi-center trial involved 1,443 enrolled patients at 105 sites in the US and Canada who were randomized 2:1 to remote monitoring or conventional groups. Patients participating in the Trust trial had either a single chamber or dual chamber ICD.
Niraj Varma, Trust principal investigator, Cleveland Clinic, said: “The data demonstrates that the Biotronik home monitoring system safely reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events. Based on the results from this large-scale clinical trial, I believe remote monitoring may improve the way physicians care for patients with implanted cardiac devices.”