2 results
Approved WMOCompleted
Demonstrate that the remote management system (Carelink, study group) reduces the time from device detected event onset to clinicaldecision for arrhythmias, cardiovascular disease progression,and system issues compared to patients receiving only in-…
Approved WMOCompleted
Safety: To provide scientific evidence that use of the VAS is safe as measured by the incidence of early-onset serious adverse events (SAEs).Effectiveness: To provide scientific evidence that use of the VAS provides an effective treatment for…