FDA Clears Abbott's New TactiCath Ablation Catheter for Atrial Fibrillation

Posted on January 22, 2019 by Medtech[y] Staff


Abbott ($ABT) today announced FDA approval of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation (AFib). The approval further expands Abbott's portfolio of cardiac ablation tools that integrate with the company's EnSite Precision™ cardiac mapping system to help physicians develop more precise images of the heart during cardiac ablation procedures.

Similar to Abbott's other sensor enabled mapping and ablation treatment catheters, TactiCath (Sensor Enabled) SE delivers more precise images of the heart overlaid with real-time electrical activity information. The catheter also utilizes the advanced ergonomic design found in the company's FlexAbility™ ablation catheter for superior reach and maneuverability during cardiac ablation procedures.

"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, M.D., an electrophysiologist at Sequoia Hospital in Redwood City, Calif., and one of the first physicians to treat patients with the newly FDA-approved catheter. "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."

Cardiac ablation has come under a bit of scrutiny lately after the CABANA Trial showed that ablation is not superior to drug therapy for CV outcomes at 5 years among patients with new-onset or untreated AF that required therapy.

It should be noted that there have been many technological advancement in ablation technologies since the CABANA Trial started.

Boston Scientific's Ken Stein told EP Vantage that technology has moved on in the eight years it has taken Cabana to conclude: “There’s been a huge evolution in the technology used for ablation, and even in our understanding of the best approaches to atrial fibrillation. In a lot of respects this is a worst-case analysis.”

What's Changed with Cardiac Ablation Technology Since the CABANA Trial?

Physicians have begun exploring the use of new tools such as "contact force" technology during ablation procedures to help them avoid applying too much pressure to heart tissue (resulting in complications) or insufficient pressure (which may reduce the effectiveness of the procedure). In addition, Abbott has also invested in technology to improve the accuracy of cardiac mapping to support cardiac ablation procedures.

Over the last two years, Abbott has expanded offerings within its electrophysiology portfolio to drive new growth and build on the company's leadership. In addition to new clinical trials to further build clinical evidence surrounding cardiac ablation, the company has also launched the Advisor™ HD Grid Mapping Catheter, Sensor Enabled, and the FlexAbility™ Ablation Catheter, Sensor Enabled.

"TactiCath SE directly supports our goal of supporting fast, effective and safe cardiac ablation procedures," said Srijoy Mahapatra, M.D., FHRS, medical director of Abbott's Electrophysiology business. "As more physicians turn to cardiac ablation to treat AFib, Abbott's goal is to equip them with the most advanced ablation catheters combined with the most advanced cardiac mapping on the market."

One of the most common cardiac arrhythmias in the world, AFib can affect how efficiently the heart pumps blood through the body, causing symptoms such as dizziness, shortness of breath or lightheadedness. The condition can also increase a person's risk of stroke. To treat conditions like AFib, physicians can use ablation catheters to scar tissue in the heart that is generating abnormal electrical signals and disrupting a patient's natural heartbeat. Abbott cardiac ablation technology is currently used to treat patients in more than 84 countries worldwide.

You can read the full report of the CABANA Trial here.