Abbott Snags Two New Electrophysiology Product Approvals

Two of Abbott’s electrophysiology products have recently received regulatory approval, one in Europe and the other in the United States. The company’s TactiFlex Ablation Catheter, Sensor Enabled, an ablation catheter with a flexible tip and contact force sensing, received CE mark for treating patients with abnormal heart rhythms like atrial fibrillation (AFib). The TactiFlex Ablation Catheter SE is proven to reduce procedure time and patient exposure to radiation compared to standard power ablation, according to Abbott, and when integrated with the company’s Ensite X EP System, can deliver high-power ablation treatment while more easily adapting to the heart tissue. TactiFlex is the latest launch within Abbott’s portfolio of electrophysiology solutions designed to treat arrhythmias — especially around AFib, the most common arrhythmia.

The catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall to direct irrigation flow to the treated tissue and increase catheter stability by up to two-times for consistent therapy delivery. Now with the CE mark in hand, the TactiFlex catheter is available in Europe, Africa, Japan, and Australia. Additionally, it is currently undergoing FDA review.

"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," said Isabel Deisenhofer, MD, professor, head of the department of Electrophysiology at the German Heart Centre Munich in Germany. "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."

The company also recently received FDA approval for an expanded indication of its Flexibility Ablation Catheter, SE. The product uses a flexible tip catheter to help physicians identify abnormal signals and treat ventricular tachycardia in patients with non-ischemic cardiomyopathy (NICM), a type of heart muscle disease that prevents the heart from pumping blood effectively. NICM is associated with VT, which is a fast heart rhythm that can lead to cardiac arrest if left untreated.