ABBOTT PARK, Ill., May 8, 2017
/PRNewswire/ -- Abbott (NYSE: ABT) today announced CE Mark and
first use of the new Confirm Rx™ Insertable Cardiac Monitor (ICM),
the world's first smartphone compatible ICM that will help
physicians identify difficult to detect cardiac arrhythmias,
including atrial fibrillation (AF), to help guide therapy. Since CE
Mark approval, adoption of the device has been strong and implants
have occurred in 10 countries across Europe. The Confirm Rx ICM is designed to
continuously monitor a patient's heart rhythm and proactively
transmit information via the myMerlin™ mobile app, allowing
physicians to follow their patients remotely and accurately
diagnose arrhythmias.
With the launch of the Confirm Rx ICM in European CE Mark
countries, Abbott has established a new paradigm in the
connectivity of cardiac devices by incorporating wireless
technology, which allows the ICM to communicate directly and
securely to the app downloaded onto a patient's smartphone.
Traditional remote monitoring has required bulky handheld or
bedside transmitters, which limit patient mobility. The new
interactive myMerlin mobile app replaces these passive transmitters
and empowers patients to participate in their own care.
In addition to patient convenience, the device is slimmer than
currently available ICMs. The Confirm Rx ICM also offers intuitive
one-touch indication-based programming, and remote monitoring via
the Merlin.net™ Patient Care Network, making the technology
convenient for clinicians involved in procedure and follow up.
"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., head of electrophysiology at the Herz-und Diabeteszentrum
NRW, Ruhr-University of Bad Oeynhausen, Germany. Dr. Nölker was one of the first
physicians to implant the Confirm Rx ICM after it received CE Mark.
"The simple insertion procedure and small device size make this
technology convenient for both patients and providers. Patients can
record symptoms directly on their smartphone without the need for a
bedside transmitter or separate activator."
Christopher Piorkowski, M.D.,
head of the Department of Electrophysiology at the University of
Dresden Heart Center in Dresden, Germany, and one of the first implanters,
added: "The Confirm Rx ICM will be particularly useful in
monitoring for atrial fibrillation in my patients with paroxysmal
AF, following AF ablation and with stroke of an unknown cause. It
allows an objective way to quantify AF events to guide treatment
decisions. The smartphone compatibility engages patients and allows
better compliance to remote monitoring through a simple and
intuitive user interface. This allows clinic staff to reduce
follow-up burden and focus on reviewing transmitted data for
AF."
The myMerlin mobile app, available in over 35 languages, makes
it easy for patients to stay connected to their physicians.
Patients can record their symptoms on their own smartphone and
specify events such as fainting or if they experience a fast heart
rate. Patients can also confirm their data was transmitted to their
physician and get automatic alerts when they have missed a
scheduled transmission, saving the clinic from having to follow up
with the patient. The device also offers secure transmission of
patient data. Recently, Abbott's Merlin.net Patient Care Network
received one of the medical device industry's first Service
Organization Control certifications (SOC2 certification), further
confirming the safety and security of the company's remote
monitoring network.
"Incorporating wireless technology directly into our devices
enhances the quality of remote monitoring and patient compliance,"
said Mark D. Carlson, M.D., chief
medical officer of Abbott's cardiac arrhythmias and neuromodulation
businesses. "The Confirm Rx ICM addresses a broad range of
indications, such as syncope, palpitations and atrial fibrillation.
The technology has been designed with robust data privacy and
security measures to ensure peace of mind for both patients and
providers."
Currently the Confirm Rx ICM is available in select countries in
Europe, with full European release
expected during the second quarter of 2017. The device is
currently under review by the U.S. Food and Drug Administration.
The estimated 2017 worldwide insertable cardiac monitor market is
approximately $800 million and is
growing by more than $100 million a
year.
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