Abbott Receives the US FDA and EU Approvals for Ablation Technologies to Treat Abnormal Heart Rhythms


Abbott’s FlexAbility sensor enabled ablation catheter received the US FDA approval for a new indication. The device is now approved as a treatment option for ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy
The decision was based on the (LESS-VT) study in 600 adult patients who were randomized to either undergo treatment with a previously approved ablation device or the FlexAbility SE Ablation Catheter which showed that 80% of patients treated with the FlexAbility device were free from VT for 6mos. after the procedure & improvements were seen in overall mental & physical health
TactiFlex sensor enabled ablation catheter received CE Mark approval for arrhythmias i.e., AFib & is now available in EU, Africa, Japan & Australia

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