Abbott has secured approval from the US Food and Drug Administration (FDA) for its TactiFlex Ablation Catheter, Sensor Enabled, to conduct an ablation procedure for the treatment of atrial fibrillation (AFib).
TactiFlex is claimed to be the world’s first ablation catheter that is equipped with a flexible tip and contact force technology.
The catheter enables reduced procedure times and improved safety compared to the company’s earlier-generation catheters.
NYU Langone Heart co-director and Heart Rhythm Centre director Dr Larry Chinitz said: “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.”
Abbott has designed this catheter for use along with its EnSite X EP System to provide enhanced visualisation to physicians to enable them to accurately detect areas in the heart that need ablation.
The catheter has a tip design that features a laser-cut pattern, which flexes upon contact with the heart wall, helping to deliver fluid to the treated tissue and enabling precise positioning of the catheter for consistent therapy delivery.
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Abbott’s electrophysiology business chief medical officer Dr Christopher Piorkowsk said: “Abbott is leading the way in helping doctors manage common arrhythmias with the most holistic portfolio for this condition in the world.
“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 TactiFlex AF IDE study proved that the Abbott TactiFlex catheter is highly effective, with approximately 99.4% acute procedural success. The study demonstrated the catheter’s capability to create safe and rapid lesions for the treatment of AFib.
In addition to the US, the catheter received approval for use in Japan, Europe, Australia and Africa.