ABBOTT PARK, Ill., Aug. 4, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) today announced first
enrollments in the TactiFlex PAF IDE study to evaluate a new device
to treat people suffering from paroxysmal atrial fibrillation
(PAF), a type of irregular heartbeat. The study will evaluate the
performance of the investigational TactiFlex™ Ablation Catheter,
Sensor Enabled™ (SE) for people whose atrial fibrillation (AFib)
symptoms are unable to be managed by medication.
More than 16 million people globally are impacted by recurrent
AFib, episodes of sporadic, irregular heartbeats when the heart's
upper chambers beat out of sync with the lower chambers. People
suffering from AFib face a number of challenges to their quality of
life, including episodes of dizziness, fatigue and shortness of
breath. Long term, they also face increased risk of stroke or heart
failure.
The TactiFlex PAF IDE study will enroll 355 patients at multiple
sites worldwide. Patients enrolled in the trial will receive an
ablation procedure using Abbott's TactiFlex Ablation Catheter, SE.
Data collected from the study will be submitted to support global
regulatory approvals.
Physicians use tools, such as contact force technology, during
ablation procedures to help them apply the right amount of pressure
to the heart tissue to improve procedural effectiveness.
Additionally, physicians use magnetically sensor enabled
technology, such as the TactiCath™ Contact Force Ablation Catheter,
Sensor Enabled™, for precise location and navigation within the
heart.
"The TactiFlex device builds on prior generations of successful
technology, giving me confidence that Abbott will continue
providing options to effectively treat people living with recurrent
episodes of atrial fibrillation," said Prof. Prash Sanders, director of Centre for Heart
Rhythm Disorders at The Royal Adelaide Hospital in Adelaide, South
Australia.
The start of the TactiFlex PAF IDE trial is among a series of
product-focused activities from Abbott designed to improve patient
care and meet the needs of electrophysiologists around the world.
The company also recently secured U.S. Food and Drug Administration
(FDA) and CE Mark approval for the EnSite™ LiveView Dynamic
Display. LiveView is designed to allow data from the Advisor HD
Grid mapping catheter to be visualized in real time during cardiac
ablation procedures. The Advisor HD Grid catheter is designed to
capture information often missed with traditional mapping
catheters.
"Abbott is focused on bringing innovation to physicians that can
improve how people with atrial fibrillation are treated. The
TactiFlex Ablation Catheter, SE brings the best of Abbott's
ablation technologies into a single catheter," said Mike Pederson, senior vice president of Abbott's
electrophysiology and heart failure businesses.
The TactiFlex Ablation Catheter, SE is being clinically
evaluated as part of the TactiFlex PAF IDE – a global study – and
is not yet commercially available.
About Cardiac Ablation:
Cardiac ablation is a minimally invasive procedure that can treat
abnormally fast heartbeats by creating lesions (ablating) in small
areas of heart tissue that a physician has identified as causing
the arrhythmia. When physicians use catheter ablation to treat
cardiac arrhythmias, long flexible tubes — called catheters — are
inserted into the heart to study the arrhythmia and to deliver
radio frequency (RF) energy. Heat generated from the RF energy
creates a scar on the tissue where the abnormal heartbeats
originate; this type of ablation has become the gold standard for
treating AFib. As a result, this tissue is no longer capable of
conducting or sustaining the arrhythmia.
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
107,000 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 and
@AbbottGlobal.
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SOURCE Abbott