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FDA gives nod for Abbott’s Confirm Rx, smartphone compatible ICM

por John R. Fischer, Senior Reporter | October 26, 2017
Confirm Rx Insertable Cardiac Monitor
The FDA has cleared the world’s first and only smartphone compatible Insertable Cardiac Monitor (ICM) to aid in remote identification of cardiac arrhythmias.

Abbott’s Confirm Rx ICM will allow patients to monitor their heart rhythms and communicate any abnormalities or unusual findings to their physicians remotely without interrupting daily activities through the use of incorporated Bluetooth wireless technology.

“The Confirm Rx ICM is a device designed specifically to reduce the complexity of the implant and the recovery period,” Avi Fischer, divisional vice president and medical director of Abbott's Cardiac Rhythm Management business, told HCB News. “Our goal was to improve upon existing ICM technology by incorporating a smaller device that is easy to implant and that offers patients Bluetooth connectivity so they can use the device with their own smartphone.”

Confirm Rx can detect a range of cardiac arrhythmias, including irregular heartbeats or atrial fibrillation, and allows physicians to quickly and remotely diagnose potentially dangerous conditions.

The ICM connects to a smartphone, eliminating the need for a separate monitoring device, and limits all communication to a single authenticated myMerlin mobile app which allows patients to track symptoms, sync data with a clinic at any time and view transmission history without contacting clinics to confirm data transfers.

Patients also can use the app to record symptomatic events on their phones without the need for added hardware such as handheld activators or bedside transmitters. Both the ICM and app encrypt all wireless communication.

The device is the slimmest insertable cardiac monitor available and is implanted under the skin in a minimally-invasive outpatient procedure that is generally less than ten minutes with the patient under local anesthesia. The slim design assists in improving patient comfort and makes the device virtually invisible once implanted. Following the procedure, patients can return home the same day.

Fischer says that Confirm Rx could especially benefit people with suspected arrhythmias that traditional short term monitors are unable to identify.

“There are a number of conditions such as infrequent or difficult to identify arrhythmias, palpitations, atrial fibrillation and syncope where these devices are particularly useful,” he said. “Essentially, this device may be appropriate for any patient whose symptoms may indicate suspected arrhythmias, but whose condition may not be detected by traditional short term monitoring options such as Holter monitors.”

The FDA recently cleared Abbott's Full Maglev HeartMate 3 Left Ventricular Assist System and MR-conditional labeling for its Ellipse ICD.

The device is approved for use in Europe and Canada.

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