The FDA has cleared Abbott’s smartphone-compatible insertable cardiac monitor (ICM), the first and only device of its kind in the U.S. This provides patients and physicians with another way to monitor and diagnose abnormal heart rhythms.
Implanted in the chest, an ICM continuously monitors a patient’s heart rhythm. Abbott’s Confirm Rx ICM transmits heart rhythm data via Bluetooth to a smartphone. Patients may use the myMerlin app to view this data and add notes that may be helpful for their physicians. The app also sends the data to the physician’s office on a preset schedule.
Abbott picked up both the Confirm Rx device and the my Merlin app in its $25 billion acquisition of St. Jude Medical.
Connecting the ICM to a smartphone eliminates the need for a bulky bedside transmitter and separate handheld activator, Abbott said. This means a patient may record symptoms at any time and transmit them to their doctor without waiting for a nightly sync, as with a traditional transmitter.
"Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care," said Avi Fischer, M.D., divisional vice president and medical director of Abbott's Cardiac Rhythm Management unit, in a statement. "By offering a device that uses Bluetooth wireless technology from the patient's smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heartbeats without requiring the patient to use a separate or cumbersome recording device."
ICMs are currently used to assess symptoms, such as palpitations, which could be caused by an arrhythmia, according to Medscape. They may also have an “emerging role” in managing patients with atrial fibrillation and patients at risk of ventricular arrhythmias.
“The Confirm Rx ICM device will be an important tool for diagnosing patients with suspected arrhythmias, such as those who have experienced fainting or palpitations," said Georg Nölker, M.D., of the Herz-und Diabeteszentrum NRW, Ruhr-University in Germany, at the time.
You can read the press release below
Oct. 23, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) has secured U.S. Food and Drug Administration (FDA) clearance for the Confirm Rx™ Insertable Cardiac Monitor (ICM), the world's first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. With FDA clearance Abbott can now provide U.S. patients a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and being able to engage in their health care.An arrhythmia is an abnormal heart rhythm that develops when disease or injury disrupts the heart's electrical signals, causing the heart to beat erratically. As the heart begins to beat too fast or too slow, changes in blood flow can expose patients to symptoms such as palpitations, dizziness, shortness of breath or fainting."Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care," said Avi Fischer, M.D., divisional vice president and medical director of Abbott's Cardiac Rhythm Management business. "By offering a device that uses Bluetooth® wireless technology from the patient's smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heart beats without requiring the patient to use a separate or cumbersome recording device."Abbott's insertable cardiac monitors have helped advance how physicians remotely monitor patients for abnormal heart rhythms. By incorporating Bluetooth® wireless technology, Abbott has advanced remote monitoring by allowing patients to connect their ICM to their smartphone via the myMerlin™ mobile app. Once implanted—just under the skin in the chest during a quick, minimally-invasive outpatient procedure—Confirm Rx continuously monitors heart rhythms to detect a range of cardiac arrhythmias, including irregular heartbeats, or atrial fibrillation.Data collected by the device is then securely transmitted to a patient's physician via the mobile app on a schedule set by the clinic. The app also allows patients to record symptomatic events from their own smartphone without the need for additional hardware such as handheld activators or bedside transmitters.The Benefits of the Confirm Rx ICMThe Confirm Rx ICM is the world's first insertable cardiac monitor that combines a quick and minimally invasive procedure with a device that uses Bluetooth® wireless technology, allowing patients to connect using a mobile app downloaded to their own smartphone. The device and mobile app are designed to allow for:Continuous heart monitoring using the patient's smartphone to record episodes of irregular heartbeat.The ability for patients to easily send their heart rhythm information to their doctor without interrupting daily activities.A discreet implant—the slimmest insertable cardiac monitor available today.While the Confirm Rx ICM continuously monitors for abnormal heart rhythms and transmits data to a patient's physician, the myMerlin app also allows patients to track symptoms proactively, sync their data with their clinic at any time, and view their transmission history without having to contact their clinic to confirm successful data transfers.The Confirm Rx ICM limits communication to a single authenticated myMerlin mobile app. The Confirm Rx ICM and the myMerlin mobile app encrypt all wireless communications using the highest standards in mobile security.About Abbott:At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life.
Photo Credit: Abbott