Abbott has received a CE mark for its TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people with abnormal heart rhythms like atrial fibrillation (AFib).

The company also secured the US Food and Drug Administration (FDA) approval for an expanded indication of its FlexAbility Ablation Catheter, Sensor Enabled (SE) to treat patients with complex heart conditions.

The German Heart Centre department of electrophysiology head Isabel Deisenhofer said: “When we treat complex ablation cases for people battling arrhythmias, we want to eliminate the arrhythmia and get our patients back to living their lives.

“The TactiFlex catheter’s data around using high-power during ablation will be game-changing for patients. When you combine these tools with Abbott’s EnSite X EP System, the innovation is truly opening new doors in patient care.”

Abbott claimed that its TactiFlex Ablation Catheter, SE, is the world’s first ablation catheter designed with a unique flexible tip and contact force sensing.

It reduces procedure times and patients’ exposure to radiation than standard power ablation.

When integrated with the company’s EnSite X EP System, the TactiFlex catheter is said to deliver high power while adapting to the heart tissue compared to conventional catheters.

The EnSite X EP System is used to accurately identify areas in the heart that require an ablation treatment.

Abbott’s TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall to guide irrigation flow to the treated tissue.

In the TactiFlex AF IDE study, the catheter created fast, safe lesions to treat the patient’s arrhythmia for the first time with more than 99% acute procedural success.

The TactiFlex catheter is currently available in Europe, Africa, Japan, and Australia, and is being reviewed by the FDA for pre-market approval.

Abbott’s FlexAbility Ablation Catheter, SE, is a flexible tip catheter that allows physicians to identify abnormal signals and treat ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy (NICM).

NICM is a type of heart muscle disease that obstructs the heart’s blood pumping and is associated with VT, a fast heart rhythm that can lead to cardiac arrest if untreated

In the LESS-VT study, FlexAbility Ablation Catheter, SE, was successful in 80% of study participants, making them free from VT for at least six months post-procedure.