Insertable Bluetooth arrhythmia monitoring system nets FDA clearance
Click Here to Manage Email Alerts
Boston Scientific announced it received clearance from the FDA for the company’s new insertable cardiac monitor system.
The new implantable monitor (LUX-Dx) is a long-term device designed to detect arrhythmias associated with atrial fibrillation, atrial flutter, rhythm pause, bradycardia and tachycardia and to distinguish arrhythmias whenever programmed thresholds or parameters are exceeded, according to a press release from the company.
According to the release, the system uses a dual-stage algorithm to detect and verify potential arrhythmias before an alert is sent to clinicians. In addition, remote programming capabilities via the company’s data management website (LATITUDE Clarity, Boston Scientific) can allow clinicians to adjust arrhythmia detection settings without an in-person visit.
"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," Kenneth Stein, MD, senior vice president and chief medical officer, Rhythm Management and Global Health Policy at Boston Scientific, said in the release.
According to the release, patients will also be provided with a mobile device, preloaded with an app (MyLUX, Boston Scientific) that connects to their implanted device via Bluetooth and transmits data to the data management system daily.
"The LUX-Dx ICM System represents a significant step forward in developing the diagnostic portfolio for Boston Scientific," Scott Olson, senior vice president and president of Rhythm Management at Boston Scientific, said in the release. "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."
Collapse
Click Here to Manage Email Alerts