ABBOTT PARK, Ill., 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 ICM
The 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. Today, 94,000
of us are working to help people live not just longer, but better,
in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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SOURCE Abbott