Boston Scientific (NYSE:BSX) today said it received FDA 510(k) clearance for its Lux-Dx Insertable Cardiac Monitor System.
The system is a long-term diagnostic device that is implanted into patients to detect arrhythmias associated with atrial fibrillation, cryptogenic stroke and syncope.
Lux-Dx is designed with a dual-stage algorithm that can detect and verify potential arrhythmias before sending an alert to clinicians. The device uses the Latitude Clarity Data Management System to enable remote programming and allow physicians and care teams to adjust event detection settings without requiring in-person appointments.
“For physicians, receiving accurate monitoring data and having remote access to programming provides the opportunity to operate with more efficiency and confidence,” senior VP and chief medical officer of rhythm management and global health policy Kenneth Stein said in a news release. “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.”
The dual-stage algorithm on the device can be programmed to identify atrial fibrillation, atrial flutter, rhythm pause, bradycardia and tachycardia episodes. It also allows the device to detect arrhythmias each time established thresholds or parameters are exceeded. Additional levels of verification filters are applied to catch false positive detections before alerts are sent.
Patients are also provided a mobile device that is preloaded with the MyLux app that connections through Bluetooth to the ICM device. The app can transmit data daily or as needed to the Latitude Clarity Data Management System to give physicians and care teams timely access.
“The LUX-Dx ICM System represents a significant step forward in developing the diagnostic portfolio for Boston Scientific,” senior VP and president of rhythm management Scott Olson said. “The addition of this new offering, alongside existing products and services, affirms our commitment to providing meaningful innovations for the detection and treatment of patients with cardiac arrhythmias.”
Boston Scientific said it would begin a limited market release of the system immediately in the U.S. with a full launch coming later this year.