Boston Scientific has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its LUX-Dx insertable cardiac monitor (ICM) system.

The LUX-Dx ICM is a new long-term diagnostic device implanted in patients for the identification of arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.

Boston Scientific rhythm management and global health policy chief medical officer and senior vice president Dr Kenneth Stein said: “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 new LUX-Dx ICM system features the dual-stage algorithm

Boston Scientific has provided the new LUX-Dx ICM system with a dual-stage algorithm, which enables to identify and verify potential arrhythmias before an alert is sent to clinicians, helping to offer useful data for clinical decision-making.

The dual-stage algorithm can be programmed to detect AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes, as well as enables the device to identify arrhythmias each time established thresholds or parameters are exceeded.

Later, an additional level of verification filters is applied to facilitate false positive detections before an alert is sent.

The remote programming capabilities of the device through the Latitude Clarity data management system website enables physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, said the company.

Boston Scientific will immediately commence a limited market release of the new ICM system, while the full commercialisation of the system will be fully commenced by the end of this year.

Boston Scientific rhythm management president and senior vice president Scott Olson said: “The LUX-Dx ICM System represents a significant step forward in developing the diagnostic portfolio for Boston Scientific.

“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.”

Earlier this month, Boston Scientific launched its DIRECTSENSE Technology, a tool for monitoring the effect of radiofrequency (RF) energy delivery during cardiac ablation procedures in the US.