First FDA Approval for Contact Force-Sensing Atrial Fibrillation Ablation Catheter

Cardiac Arrhythmia specialist Biosense Webster, Inc., part of the J&J empire, has received U.S. FDA approval for its THERMOCOOL® SMARTTOUCH® Catheter. This device is the first therapeutic catheter approved in the U.S. that enables direct and real-time measurement of contact force during catheter ablation procedures for patients suffering from drug-resistant paroxysmal atrial fibrillation (Afib), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.

Background

Biosense Webster, Inc. says it is the global leader in the science of diagnosing and treating heart rhythm disorders, a claim that is supported by the newly announced FDA approval of its THERMOCOOL® SMARTTOUCH® Catheter. Despite the fact that we’ve heard a bit about so-called contact force sensing ablation catheters in the past twelve months, this one has beaten Endosense’s offering to FDA approval.

So what’s it all about, this force-sensing? Well, there is clinical support for the notion that by providing contact force stability when applying radiofrequency (RF) energy against the heart wall during catheter ablation, delivery of ablative energy can be optimised and rendered consistent. This has been shown to improve outcomes, the avoidance of inconsistent tissue contact translating into better outcomes, the avoidance of additional treatment due to incomplete isolation, and avoidance of tissue injury due to too much force. The THERMOCOOL® SMARTTOUCH® Catheter provides direct, real-time quantitative feedback graphically displayed on the company’s CARTO® 3 System upon tissue contact. Without this technology, catheter tip-to-tissue contact has to be estimated through other indirect measures such as electrogram parameters and impedance but they have been shown to be poor predictors of contact force.1

Physician comments

“The THERMOCOOL® SMARTTOUCH® Catheter is an important new device that will benefit the electrophysiology community, as it will enable us to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation,” said Andrea Natale, MD, Primary Investigator of the SMART-AF Trial, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX and part of the company’s Scientific Advisory Board. “Data from the SMART-AF Trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes. The use of contact force-sensing technology has emerged as a critical tool in delivering optimal outcomes in the treatment of patients with atrial fibrillation and represents a major advancement for the clinical community.”

Company comments

“We are pleased to be able to introduce this important advancement to help clinicians enhance the quality of care they deliver for the thousands of U.S. atrial fibrillation patients in need of alternative treatments to drug therapy,” said David Shepherd, Worldwide President of Biosense Webster. “The burden of atrial fibrillation on quality of life, morbidity and mortality is well-documented and we are committed to developing life-enhancing therapies to continue addressing unmet needs in this space.”

References

1 Nakagawa H, Kautzner J, Natale A, et al. Locations of high contact force during left atrial mapping in atrial fibrillation patients: electrogram amplitude and impedance are poor predictors of electrode-tissue contact force for ablation of atrial fibrillation. Circ Arrhythm Electrophysiol 2013;6:746-53.

2 Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial ?brillation in the United States.Circ Cardiovasc Qual Outcomes 2011;4:313–320.25

Source: Biosense Webster, Inc., Business Wire

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