Sam Brusco, Associate Editor05.19.23
Abbott Labs has received U.S. Food and Drug Administration (FDA) approval for its TactiFlex ablation catheter, Sensor Enabled. According to Abbott, it’s the world’s first ablation catheter with flexible tip and contact force technology.
The TactiFlex catheter may result in reduced procedure times and better safety when compared to the company’s previous generation catheters.1,2
"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, M.D., director of the Heart Rhythm Center and co-director of NYU Langone Heart, told the press. "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."
The TactiFlex catheter is designed for use with Abbott’s EnSite X EP system, a heart-mapping system that lets physicians view and precisely identify heart areas that need ablation. It features a tip design with a laser-cut pattern that flexes in contact with the heart wall. This helps direct fluid to the treated tissue1 and allows for more accurate catheter positioning.
"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 TactiFlex catheter is also approved for use in Europe, Japan, Africa and Australia.
References
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.
The TactiFlex catheter may result in reduced procedure times and better safety when compared to the company’s previous generation catheters.1,2
"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, M.D., director of the Heart Rhythm Center and co-director of NYU Langone Heart, told the press. "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."
The TactiFlex catheter is designed for use with Abbott’s EnSite X EP system, a heart-mapping system that lets physicians view and precisely identify heart areas that need ablation. It features a tip design with a laser-cut pattern that flexes in contact with the heart wall. This helps direct fluid to the treated tissue1 and allows for more accurate catheter positioning.
"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 TactiFlex catheter is also approved for use in Europe, Japan, Africa and Australia.
References
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.