Medscape... NICE, FRANCE – A small usability study testing a miniaturized implanted cardiac monitoring system (Reveal LINQ, Medtronic) in European patients shows the device successfully resulted in the wireless transmission of data in nearly 70% of patients who received the implant. After a systems upgrade to the firmware, however, the transmission success rate improved to 79.2%, report investigators. The cardiac monitor, which has a battery life of approximately three years, is significantly smaller than other sensors. Compared with the Reveal XT implantable monitor, the LINQ system is 87% smaller than its predecessor, although it contains more storage capacity. "It's a very small system," said Dr Helmut Pürerfellner (Public Hospital Elizabethinen, Linz, Austria). "If you lose it, you won't find it."
At CardioStim 2014 , Pürerfellner presented data on the sensing performance and data transmission as part of the Reveal LINQ usability study. In total, 30 patients were included in a phase 1 study, which was designed to support European market approval. The primary indication for the device was syncope (63.3%), but suspected atrial fibrillation (AF) and AF management were other indications. Just one patient had a cryptogenic stroke leading to the sensor implant. Reveal LINQ and Reveal XL [Source: Medtronic]
Pürerfellner said the study met its primary end point, that being the successful wireless transmission of ECG data. The secondary end point, which was R-wave amplitude, was also met. In total, an R-wave >200 µV was detected in 96% of patients. Physician and patient surveys showed positive results with regard to acceptance and satisfaction. There was no device migration observed.
Pürerfellner acknowledged "indication creep" with the cardiac sensor. Initial implantable loop recorders were implanted almost entirely in patients with syncope. As for how successful the device might be in terms of detecting and managing AF, Pürerfellner said the phase 2 study, which includes 120 patients, is specifically designed to determine if the LINQ can detect AF and will be presented soon. Anecdotally, he said he has implanted the system 13 patients and observed one false-positive for AF detection.
In February 2014, LINQ was approved by the US Food and Drug Administration (FDA) and gained CE Mark approval in Europe.