Insertable cardiac monitoring device
LUX-Dx™ implantable cardiac monitoring (ICM) system was developed by Boston Scientific for the long-term diagnosis of arrhythmias associated with conditions such as atrial fibrillation and syncope.
LUX-Dx system enhances patient experience with interactive technology, remote data management and mobile device. It facilitates advanced detection and predictive alerts while streamlining workflow for long-term monitoring of arrhythmias.
Boston Scientific filed its 510(k) submission for the LUX-Dx with the US Food and Drug Administration (FDA) in December 2019 and received clearance for commercialisation in the US under Class II medical device category in June 2020.
The company started a limited release of the product in the US market, with the complete product launch expected by the end of 2020.
LUX-Dx is an insertable diagnostic-only device that comprises an insertable monitor, implant tools, and a smartphone app. It is the first ICM device with remote-programming capability and paired with a dual-stage arrhythmia detection algorithm.
A pre-loaded mobile device with the MyLUX™ software mobile application is provided to the patient following the implantation of the monitor. The application connects to the implanted monitoring device via Bluetooth.
The dual-stage algorithm is programmed within the ICM device for the identification of cardiovascular conditions such as atrial flutter, atrial fibrillation, rhythm pause, palpitations, cryptogenic stroke, episodes of bradycardia and ventricular tachycardia.
The software also allows the device to detect arrhythmia if the provided parameters or established thresholds are exceeded.
Another layer of verification filter is applied to identify false-positive detections before sending the alert.
Data from the monitoring device is transmitted to the LATITUDE Clarity Data Management System via the MyLUX app based on the requirement. This gives the healthcare professionals with the ability to access the vital heart information of the patient and speed up clinical decisions by reviewing monitoring data with high sensitivity.
LATITUDE Clarity™ Data Management System website renders the remote programming ability to the system. It boasts a unique feature that allows the clinicians to adjust settings of event detection in the device without the need for a patient appointment in-person.
LATITUDE is designed for the seamless transfer of patient and device information as programmer reports to the clinic electronic medical record (EMR) or device management system.
The next generation LUX-Dx insertable cardiac monitor is under investigation as a chronic monitoring platform for the detection of various disease conditions with improved sensors.
It will be designed to diagnose heart failure with physiologic sensors and HeartLogic™, a heart failure diagnostic tool. It will also record heart sounds, thoracic impedance, respiration, and night heart rate.
Boston Scientific is a medical device manufacturing company headquartered in Marlborough, Massachusetts, US. The company focusses on addressing the unmet needs of patients with reduced healthcare costs.
The LUX-Dx device, HeartLogic Heart Failure Alert, Single Shot Cryo & RF are the growth accelerators of the company’s rhythm management sector, expected to reach approximately $2.5bn market by 2022.
The device will strengthen the company’s diagnostic portfolio by adding innovations to diagnose and treat patients with cardiac arrhythmias.
In addition to LUX-Dx, Boston Scientific’s product line in the electrophysiology segment of rhythm management includes HeartLogic Heart Failure Diagnostic, RHYTHMIA Hdx™ Mapping System, WATCHMAN™ Left Atrial Appendage Closure Device, and EMBLEM™ MRI S-ICD System.
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