ABBOTT PARK, Ill., Sept. 22, 2017
/PRNewswire/ -- Abbott (NYSE: ABT) today announced U.S. Food
and Drug Administration (FDA) approval for magnetic resonance
(MR)-conditional labeling for one of Abbott's most widely-used
implantable cardioverter defibrillators (ICD) and associated high
voltage leads. The approval of MR-conditional labeling for the
Ellipse™ ICD with the Tendril MRI pacing lead and Durata and
Optisure high voltage leads adds another patient-centric benefit to
the device and will help further improve access for patients
suffering from abnormally fast heart rhythms who need an ICD and
who may need an MRI scan in the future.
When electrical signals in the lower chamber of the heart fire
erratically, the heart can beat abnormally fast – a condition known
as ventricular tachycardia or tachyarrhythmia – which in
turn leaves the heart unable to pump blood effectively. In addition
to symptoms such as light-headedness, chest pains and shortness of
breath, over time the condition can lead to a potentially
life-threatening arrhythmia, heart failure, stroke or cardiac
arrest. Abbott's ICD devices can monitor for and detect abnormally
fast heart rhythms and deliver electricity to the heart to restore
the heart's natural rhythm.
The new MR-conditional labeling for the Ellipse ICD allows
patients to undergo an MRI scan if needed. In addition, patients
previously implanted with an Ellipse device and Durata or Optisure
leads can now undergo MRI scans.
"When you consider the number of patients each year who rely on
the lifesaving treatment delivered by an ICD device, it is critical
to continually innovate to provide new benefits to people battling
complex arrhythmias and other cardiac conditions," said
Mark Carlson, M.D., chief medical
officer for Abbott's Cardiac Arrhythmias and Heart Failure
division. "By expanding our portfolio of MRI compatible devices,
we're adding another benefit onto an ICD device that was designed
hand-in-hand with physicians to optimize therapy for patients."
The smaller shape and size of Ellipse ICD helps improve patient
comfort once implanted and Abbott engineered the device with
features designed to optimize ICD therapy and improve patient
safety. The features, known as Abbott's TailoredTherapy™ approach,
include:
- DeFT Response™ Technology: Allows physicians to adapt
how therapy is delivered by the Ellipse ICD to ensure each patient
receives therapy based on their unique need. The feature also helps
ensure successful therapy delivery without the need to deliver an
initial shock at the time of implant.
- SecureSense™: Abbott's SecureSense algorithm offers an
additional level of protection for patients by providing proper
sensing within the heart even in the presence of external
interference (known as "lead noise") to safeguard against
unnecessary therapy being delivered to the patient.
- DynamicTx™: With Abbott's DynamicTx algorithm,
physicians can be confident that their patient's devices are
consistently evaluating the condition of the lead and adapting the
path of the electrical impulse to deliver appropriate therapy.
As a further benefit, all therapy and other data captured by the
Ellipse ICD can be directly, securely and wirelessly sent to a
patient's physician through the Merlin.net™ Patient Care Network.
This communication allows physicians to remotely monitor their
patient's therapy and assess any need for intervention.
The latest labeling ensuring Abbott's Ellipse ICD is MRI ready
follows approval earlier this year of Abbott's Assurity MRI
pacemaker and prior MR-conditional labeling approvals in
Europe, allowing Abbott to further
build its portfolio of MRI ready products. The company continues to
work with regulatory agencies around the world to secure approval
for MR-conditional labeling for additional commonly-implanted
pacemakers, implantable cardioverter defibrillators (ICDs) and
cardiac resynchronization therapy (CRT) devices.
ABOUT ICD TECHNOLOGY
An ICD is an advanced high
voltage implantable device that treats potentially lethal,
abnormally fast heart rhythms, which often lead to sudden cardiac
death. Each year, more 300,000 ICDs are implanted worldwide.
A lead is a thin insulated wire that is placed through the vein
as part of a pacemaker or ICD implantation procedure. The tip of
the lead is attached to the heart tissue, and the other end
connects to the ICD. A lead carries electrical impulses from the
ICD to the heart and transmits information from the heart back to
the implanted device.
Some ICDs are referred to as "MR-conditional" or "MRI ready."
This means that they are designed to allow patients to safely
undergo an MRI scan under certain conditions. By having an ICD
implanted that allows MRI scans, patients have access to an imaging
modality that offers important information and highly detailed
images to medical professionals when making a patient
diagnosis.
For more information about Abbott's focus on cardiac rhythm
management, visit www.sjm.com/en/patients/arrhythmias.
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