Abbott Gains FDA Clearance for One Cardiac Ablation Catheter, CE Mark for Another

Abbott has received FDA clearance for a new indication for its FlexAbility sensor enabled ablation catheter for ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy.

The expanded indication for the FlexAbility catheter comes after the company conducted a pre-market trial which showed that 80 percent of 600 study participants were free from VT for at least six months after the procedure.

Abbott has also gained a CE mark for its TactiFlex ablation catheter for common arrhythmias like atrial fibrillation. The Tactiflex catheter has a flexible tip and contact force sensing which is “proven to reduce procedure times and patients’ exposure to radiation” compared to standard power ablation, the company said.