The US Food and Drug Administration (FDA) has granted 510(k) clearance to LUX-Dx Insertable Cardiac Monitor (ICM) System developed by Boston Scientific.
LUX-DxICM System is a long-term diagnostic device implanted in patients to detect arrhythmias related to conditions, including atrial fibrillation (AF), cryptogenic stroke and syncope.
It offers actionable data for clinical decision-making, using a dual-stage algorithm that detects and then verifies potential arrhythmias before clinicians receive an alert.
The LATITUDE Clarity Data Management System website provides remote programming capabilities to the device. This enables physicians and care teams to adjust event detection settings without an in-person patient appointment.
Additionally, the dual-stage algorithm within the LUX-Dx ICM System can be programmed to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes.
It also enables the device to detect arrhythmias each time established thresholds or parameters are exceeded.
Furthermore, patients are provided with a mobile device preloaded with the MyLUX app after implant. It connects to their ICM device via Bluetooth.
The app offers physicians and care teams timely access to vital information by transmitting device data daily, or as needed, to the LATITUDE Clarity Data Management System.
Boston Scientific Rhythm Management and Global Health Policy senior vice-president and chief medical officer Kenneth Stein said: “For physicians, receiving accurate monitoring data and having remote access to programming provides the opportunity to operate with more efficiency and confidence.
“The LUX-Dx ICM 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.”
Boston Scientific said that it will soon start a limited market release of the LUX-Dx ICM System in the US. The company is planning the full launch of the product later this year.
