Boston Scientific's LUX-Dx insertable cardiac monitor cleared by FDA

Boston Scientific announced Monday that it received FDA 510(k) clearance for the LUX-Dx insertable cardiac monitor (ICM) system, which the company said is the first ICM device with remote programming paired with a dual-stage arrhythmia detection algorithm. Specifically, the long-term diagnostic device is implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.  

Kenneth Stein, chief medical officer for rhythm management and global health policy at the company, remarked that the system "is designed to provide physicians the ability to accelerate critical clinical decisions and allow them to spend more time focusing on patient outcomes by reviewing monitoring data and catching false-positive detections without compromising sensitivity."

According to Boston Scientific, the dual-stage algorithm detects and then verifies potential arrhythmias before an alert is sent to clinicians. In addition, the LATITUDE Clarity data management system website allows remote programming of the device, including enabling clinicians to adjust event detection settings without requiring in-person patient visits, "a feature unavailable on any other ICM currently on the market," the company said.

False-positive detection

The algorithm can be programmed to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes, and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded. "An additional level of verification filters is then applied, which was developed to catch false-positive detections before an alert is sent,” Boston Scientific explained. Further, a mobile device preloaded with the MyLUX app connects via Bluetooth to the patient's ICM device, with the app transmitting device data daily, or as needed, to the LATITUDE Clarity data management system.

Boston Scientific said it will begin a limited US market release of the LUX-Dx ICM system immediately, with full launch commencing later this year.

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