LONDON – Boston Scientific Corporation (NYSE: BSX) today announced the European launch of the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, a long-term diagnostic device inserted under the skin of patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.

The LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrythmias before an alert is sent to clinicians. The algorithm can be programmed remotely to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes, and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded.

In addition, this technology also has the potential to support patient follow up of electrophysiology procedures through remote monitoring, which could play an important role in supporting the efficiency of medical teams. Remote patient monitoring can help clinicians prioritise care when hospital teams are under pressure by providing guidance for triaging each patient.

“We had the opportunity to be one of the first in the UK to implant the LUX-Dx™ ICM. Signals seen so far at implant have been providing great sensing and amplitude of P waves as well as fibrillation waves. Patients have been happy and confident with the ease of setup and use of their patient phone.” said Lydia Bradley, CRM Service Lead Physiologist & ACP at the Hospital is Royal Wolverhampton NHS Trust, England. “Ease of use, clarity of the information and intuitive platform are invaluable in helping us make prompt decisions.”

Following implantation of the LUX-Dx ICM System, patients are provided with a mobile device preloaded with the MyLUX™ app which connects via Bluetooth® to their ICM device. The app transmits device data daily, or as needed, to the LATITUDE Clarity™ Data Management System, giving physicians and care teams timely access to vital information.

“We are excited to expand our reach into the cardiac diagnostic field with the LUX-Dx ICM System,” said Angelo De Rosa, vice president and general manager EMEA, Rhythm Management, Boston Scientific. “Signal quality, dual-stage algorithm and remote programming will further unlock the potential of remote patient monitoring technology in Europe and reinforce the therapy offerings we can provide to physicians, from diagnosis to treatment.”

The LUX-Dx ICM System has CE Mark in Europe and U.S. Food and Drug Administration 510(k) clearance. For more information on the LUX-Dx ICM System, please click here.