FDA Approves TactiCath Catheter for Atrial Fibrillation

The US Food and Drug Administration (FDA) has approved a new cardiac ablation catheter for the treatment of atrial fibrillation—the TactiCath Contact Force Ablation Catheter, Sensor Enabled.

The TactiCath Contact Force Ablation Catheter (Sensor Enabled) SE is used to scar tissue in the heart that contributes to the abnormal electrical signals that disrupt the heartbeat rhythm of a patient with atrial fibrillation. The TactiCath catheter integrates with Abbott’s EnSite Precision cardiac mapping system.

"Cardiac ablation has become a front-line therapy in the fight against conditions like atrial fibrillation in part because of improvements to the technology available today," said Roger Winkle, MD, an electrophysiologist at Sequoia Hospital in Redwood City, California, and one of the first physicians to treat patients with the newly FDA-approved catheter, in a statement. "The Abbott TactiCath SE ablation catheter represents one of those major improvements, and offers an incredibly powerful, yet easy to use, combination of advanced technologies to improve ablation procedures."

The Centers for Disease Control and Prevention estimate that 2.7—6.1 million people in the United States have atrial fibrillation, and that number is expected to rise as the population ages. Atrial fibrillation increases a patient’s stroke risk by 4 to 5 times compared to those who do not have the condition. Additionally, strokes caused by complications from atrial fibrillation tend to be more severe than strokes from other causes.

Previous research has shown that cardiac ablation procedures for atrial fibrillation can lower mortality rates and reduce the need for hospitalization due to heart failure.

"TactiCath SE directly supports our goal of supporting fast, effective and safe cardiac ablation procedures," said Srijoy Mahapatra, MD, FHRS, medical director of Abbott's electrophysiology business, in a statement. Mahapatra said that Abbott seeks to provide advanced ablation catheters as well as advanced cardiac mapping to support physicians who are increasingly using cardiac ablation to treat their patients with atrial fibrillation.