Expanded Indication for Abbott Heart Catheter

FDA has approved an expanded indication for Abbott’s FlexAbility sensor-enabled ablation catheter, a flexible tip catheter that the company says helps doctors identify abnormal signals and apply therapy to treat ventricular tachycardia (VT) with non-ischemic cardiomyopathy (NICM). A company statement says its LESS-VT study was the first FDA-approved premarket trial to study the safety and effectiveness of ablation to treat VT with NICM origin.

Once treated with the FlexAbility catheter, the company says, 80% of study patients were free from VT for at least six months post-procedure. It says the data also showed significant improvements in patients’ mental and physical quality-of-life measures.

The company says the catheter has been intended for use with a compatible irrigation pump and a compatible RF cardiac ablation generator. It is intended for creating endocardial lesions during cardiac ablation procedures to treat typical atrial flutter.