- Abbott's Assert-IQ offers the world's longest battery life† for
an insertable cardiac monitor (ICM)
- The latest addition to Abbott's portfolio of connected health
devices, the Assert-IQ ICM offers long-term monitoring and remote
programming to improve connectivity to patients
- The device provides continuous monitoring for abnormal heart
rhythms while offering tools designed to help improve data
management and workflow within a physician's practice
ABBOTT
PARK, Ill., May 18, 2023
/PRNewswire/ -- Abbott (NYSE: ABT) today announced its Assert-IQ™
insertable cardiac monitor (ICM) has received U.S. Food and Drug
Administration (FDA) clearance, giving physicians a new option for
diagnostic evaluation and long-term monitoring of people
experiencing irregular heartbeats. This clearance builds on
Abbott's portfolio of connected health devices that can better help
doctors manage and treat their patients remotely.
Irregular heartbeats – known as arrhythmias – may be fleeting,
making diagnosis challenging in many patients. ICMs – small devices
with sensors inserted just under the skin of the chest – are
designed to provide constant, real-time monitoring of a person's
heart to detect and identify arrhythmias that can lead to symptoms
such as fainting, irregular pulse and shortness of breath.
While many commercially available ICMs monitor a person's heart
rhythms for a few years, Assert-IQ offers two options with a
battery life of at least three or six years to provide doctors a
new level of flexibility in diagnostic monitoring. While the
three-year option may be preferred for more traditional monitoring,
such as diagnosing fainting, heart palpitations or detections of
abnormal heart rhythms, an option offering at least six years of
battery life empowers physicians to monitor long-term. This
monitoring can be especially important when caring for people who
are undergoing therapy, have recently had a cardiac ablation
procedure or who are at risk of developing further arrhythmias such
as atrial fibrillation. In both options, advanced algorithms are
available to detect irregular heartbeats and provide clinically
actionable data.
"The Assert-IQ ICM is a significant advancement amongst the
tools that are currently available for the diagnoses of irregular
heart rhythms. Given that the device is small and is inserted just
under the skin, patients can go about their daily lives, enjoying
the activities they love, and the ICM does the work," said
Dhanunjaya Lakkireddy, M.D., medical
director of the Kansas City Heart Rhythm Institute. "With Assert-IQ
ICM's advanced algorithms, it can detect even hard-to-spot
irregularities and help physicians determine a treatment course. It
can be a very valuable tool both for short-term and long-term
management of cardiac arrhythmia disorders."
Using Bluetooth® technology, Abbott's Assert-IQ ICM
is designed to remain connected to a transmitter – usually the
person's own cell phone – where it checks heart rhythms every 20
seconds, transmitting results in real-time to the clinic's portal.
Additionally, some models of the Assert-IQ ICM family can be
remotely programmed allowing the clinician to adjust the settings
of the connected device, optimize performance and limit unnecessary
alerts or transmissions – all without requiring the patient to
visit the clinic.
The Assert-IQ ICM also offers advanced diagnostic capabilities
to provide physicians with more clinically relevant information
about the cardiovascular health of the patient, allowing care
providers to make clinical decisions faster.
"As the incidence of abnormal heart rhythms like atrial
fibrillation continue to rise, more doctors are turning to ICM
technology to monitor their patients remotely to better detect the
cause of symptoms that can impact overall health and quality of
life," said Leonard Ganz, M.D.,
divisional vice president of medical affairs and chief medical
officer of Abbott's cardiac rhythm management business. "Until now,
insertable cardiac monitors have allowed for remote monitoring of
patients but lacked the longevity needed to monitor them long-term.
Abbott's Assert-IQ ICM offers physicians a connected health device
that will help them provide the best care for their patients while
making more accurate and informed treatment decisions."
For U.S. important safety information on Assert-IQ ICM, visit:
https://bit.ly/3OoJMjE
About Abbott:
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals, and branded generic medicines. Our
115,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on
Twitter @AbbottNews.
† As of 12.31.22. Reveal LINQ‡
User Manual, LINQ II‡ User Manual, Lux Dx‡ User Manual, Biomonitor
III‡ User Manual, Biomonitor IIIm‡ User Manual
1. Medtronic. REVEAL LINQ‡ LNQ11 Insertable Cardiac Monitor and
Patient Assistant PA96000 Clinician Manual. Updated August 26, 2015. Accessed January 17, 2023.
https://manuals.medtronic.com/content/dam/emanuals/crdm/CONTRIB_215651.pdf
2. Medtronic. LINQ II‡ LNQ22 Insertable Cardiac Monitor Clinician
Manual. Updated September 01,
2022.
Accessed January 17, 2023.
https://manuals.medtronic.com/content/dam/emanuals/crdm/M032283C001B_view.pdf
3. Boston Scientific. User's Manual, Lux-Dx‡ Insertable Cardiac
Monitor System M301, 2925, 2935.
Updated July 2020. Accessed
January 17, 2023.
https://www.bostonscientific.com/content/dam/Manuals/us/current-rev-en/92216689-002_LUX-Dx_UM_en_S.pdf
4. Biotronik. Technical Manual BioMonitor III‡.
Updated December 10, 2020. Accessed
January 17, 2023.
https://manuals.biotronik.com/emanuals-professionals/?country=US&product=ImplCardMon/BioMonitor3/BioMonitor3_US
5. Biotronik. Technical Manual BioMonitor IIIm‡.
Updated December 10, 2020. Accessed
January 17, 2023.
https://manuals.biotronik.com/emanuals-professionals/?country=US&product=ImplCardMon/BioMonitor3m/BioMonitor3m_US
Brief Summary: Prior to using these devices, please review the
Instructions for Use for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events
and directions for use.
Indications for Use: The Assert-IQ™ ICM is indicated for the
monitoring and diagnostic evaluation of patients who experience
unexplained symptoms that may be cardiac-related such as:
dizziness, palpitations, chest pain, syncope, and shortness of
breath, as well as patients who are at risk for cardiac arrhythmias
such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ
ICM is also indicated for patients who have been previously
diagnosed with atrial fibrillation (AF) or who are susceptible to
developing AF. The Assert-IQ ICM is intended to be inserted
subcutaneously in the left pectoral region, also described as the
left anterior chest wall. The Assert-IQ ICM has not been
specifically tested for pediatric use.
Intended Use: The Assert-IQ ICM is intended to help physicians
and clinicians monitor, diagnose and document the heart rhythm in
patients who are susceptible to cardiac arrhythmias and unexplained
symptoms by detecting arrhythmias and transmitting data for
review.
Contraindications: There are no known contraindications for the
insertion of the Assert-IQ ICM. However, the patient's particular
medical condition may dictate whether or not a subcutaneous,
chronically inserted device can be tolerated.
Potential Adverse Events: Possible adverse events (in
alphabetical order) associated with the device, include the
following: allergic reaction, bleeding, chronic nerve damage,
erosion, excessive fibrotic tissue growth, extrusion, formation of
hematomas or cysts, infection, keloid formation and migration.
Refer to the User's Manual for detailed indications for use,
contraindications, warnings, precautions and potential adverse
events.
An Abbott mobile transmitter is available for patients without
their own compatible mobile device.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its
respective owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth
SIG, Inc.
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SOURCE Abbott