FDA approves sensor-enabled atrial fibrillation ablation catheter
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Abbott announced the FDA approved its sensor-enabled ablation catheter for treatment of atrial fibrillation.
The ablation catheter (TactiFlex Ablation Catheter, Sensor Enabled) is the first to have a flexible tip and contact force technology, according to a press release issued by the company.
As Healio previously reported, the ablation catheter received a CE mark for use in Europe in February.
Studies of the ablation catheter have shown it is associated with reduced procedure times and better safety compared with the company’s previous-generation catheters, according to the release.
The product is designed to be used with a heart mapping system (Ensite X EP System, Abbott) that allows physicians to view and identify which areas of the heart require ablation, according to the release.
“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,” Larry A. Chinitz, MD, director of the Heart Rhythm Center and co-director of NYU Langone Heart, said in the release. “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.”
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