Abbott has secured FDA clearance for its TactiFlex Ablation Catheter, Sensor Enabled, a device designed for the treatment of atrial fibrillation (AFib). This clearance marks a significant advancement in electrophysiology, offering a new tool for physicians to combat this prevalent heart rhythm disorder.
The TactiFlex catheter distinguishes itself with a flexible tip incorporating contact force technology. This design aims to improve the precision and safety of ablation procedures, potentially leading to shorter procedure times compared to earlier catheter models. The device is intended for use in patients with AFib, the most common type of arrhythmia, which affects over 37 million people worldwide, a number projected to more than double by 2050.
Enhanced Precision and Stability
The TactiFlex catheter is engineered to work in conjunction with Abbott's EnSite X EP System, a cardiac mapping system that allows physicians to visualize and pinpoint areas in the heart that need ablation. The catheter's tip includes a laser-cut pattern that flexes upon contact with the heart wall, facilitating fluid delivery to the targeted tissue and enhancing catheter stability. Abbott reports that this design provides up to two times greater stability in a beating heart, ensuring consistent therapy delivery.
Clinical Trial Success
The FDA clearance was supported by data from the TactiFlex AF IDE study, which demonstrated a high rate of acute procedural success. The study showed that the catheter effectively created fast and safe lesions to treat AFib, achieving over 99% acute procedural success. These results suggest that the TactiFlex catheter can be a valuable tool for electrophysiologists in treating AFib.
Expert Commentary
According to Larry A. Chinitz, M.D., director of the Heart Rhythm Center and co-director of NYU Langone Heart in New York City, AFib can significantly impact daily life, causing symptoms such as dizziness, chest pain, and heart palpitations. He emphasized the importance of early treatment to prevent stroke, highlighting the potential of new tools like Abbott’s TactiFlex catheter, when used with mapping systems, to safely and efficiently address the problem.
Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business, stated that the EnSite X EP System is unmatched in determining the exact location where ablation is required. He added that, 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.
