- TactiFlex™ Ablation Catheter, Sensor Enabled™, is the world's
first ablation catheter designed with a unique flexible electrode
tip and contact force sensing to treat patients with atrial
fibrillation
- When used with Abbott's EnSite™ X EP System, physicians have
better visualization allowing for more accuracy and precision with
the TactiFlex catheter, leading to reduced procedure times and
better safety
ABBOTT
PARK, Ill., May 19, 2023
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S.
Food and Drug Administration (FDA) has approved the company's
TactiFlex™ Ablation Catheter, Sensor Enabled™, the world's first
ablation catheter with a flexible tip and contact force
technology.
Used to perform an ablation procedure to treat atrial
fibrillation (AFib), the most common abnormal heart rhythm, the
TactiFlex catheter can result in reduced procedure
times1 and better safety when compared to the company's
previous generation catheters2.
More than 37 million people worldwide live with AFib3
and numbers are predicted to more than double by 2050.4
An additional five million5 cases are diagnosed every
year, indicating a growing health challenge that demands innovative
solutions for patients and their physicians.
"For those suffering from AFib, daily life can be challenging as
people often feel dizziness, chest pain and heart palpitations.
AFib can lead to stroke if left untreated, making it critical for
physicians to treat the issue as early as possible," said
Larry A. Chinitz, M.D., director of
the Heart Rhythm Center and co-director of NYU Langone Heart in
New York City. "We are entering
the next chapter of AFib ablation with new tools such as Abbott's
TactiFlex that, when used with mapping systems to accurately
identify the source of an arrhythmia, can safely and efficiently
treat the problem in ways we never thought possible a decade
ago."
New Catheter Pairs with Abbott's Other Best-in-Class
Solutions for AFib Patients
The TactiFlex catheter is
designed to be used with Abbott's EnSite X EP System, an
industry-leading heart mapping system, which allows physicians to
view and precisely identify areas in the heart that require
ablation.
Unlike other catheters on the market, the TactiFlex catheter
uses a tip design with a laser-cut pattern that flexes when in
contact with the heart wall. This helps direct fluid to the treated
tissue1 and allows for more accurate positioning of the
catheter – providing up to two-times higher stability in a beating
heart – for consistent therapy delivery.6
"Abbott is leading the way in helping doctors manage common
arrhythmias with the most holistic portfolio for this condition in
the world," said Christopher
Piorkowski, M.D., chief medical officer of Abbott's
electrophysiology business. "The EnSite X EP System is unmatched in
determining the exact location where ablation is required. Coupled
with the TactiFlex catheter, patients can now feel even more
confident that their procedure will deliver safe and effective
results."
The Abbott TactiFlex catheter generated strong clinical outcomes
in the TactiFlex AF IDE study7. The study showed the
catheter created fast, safe lesions to treat AFib with over 99%
acute procedural success.1
The TactiFlex catheter is also approved for use in Europe, Japan, Africa
and Australia.
For U.S. important safety information on Abbott's TactiFlex™
Ablation Catheter, Sensor Enabled™, visit:
https://cardiovascular.abbott/us/en/products/electrophysiology/ablation-technology/tactiflex-se-ablation-catheter/indications-safety-warnings.html.
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, nutritional 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.
1 CL1017540 TactiFlex PAF IDE PMA Report
2 Lo MY, Sanders P, Sommer P, Kalman JM, Siddiqui UR,
Sundaram S, Piorkowski C, Olson N, Madej SM, Gibson DN. Safety and
effectiveness of a next-generation contact force catheter: results
of the TactiSense trial. Clinical Electrophysiology. 2021
Aug 1;7(8):1013-21.
3 Lippi G, Sanchis-Gomar F, Cervellin G. Global
epidemiology of atrial fibrillation: An increasing epidemic and
public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi:
10.1177/1747493019897870. Epub 2020 Jan 19. Erratum in: Int J
Stroke. 2020 Jan 28;:1747493020905964. PMID: 31955707.
4 Morillo CA, Banerjee A, Perel P, Wood D, Jouven X.
Atrial fibrillation: the current epidemic. J Geriatr Cardiol. 2017
Mar;14(3):195-203. doi: 10.11909/j.issn.1671-5411.2017.03.011.
PMID: 28592963; PMCID: PMC5460066.
5 Go AS, Hylek EM, Phillips KA, et al. Prevalence of
Diagnosed Atrial Fibrillation in Adults: National Implications
for Rhythm Management and Stroke Prevention: the AnTicoagulation
and Risk Factors In Atrial Fibrillation (ATRIA)
Study. JAMA. 2001;285(18):2370–2375.
doi:10.1001/jama.285.18.2370
6 Compared to conventional 56-hole catheters.
Ambrosius Nick, Fish Jeffrey, &
Tranter John. Flexible, Kerfed Ablation Catheter Tip
Provides Superior Stability in a Bench Model APHRS 2018: Abstract
Book; 2018, October 17-18;
Taipei, Taiwan. Abstract nr
1170.
7 CL1019990 TactiFlex PAF IDE As Treated Repeat
Procedure Details
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SOURCE Abbott