FDA Approval for St. Jude’s TactiCath Quartz Contact Force Ablation Catheter for AF

Contact force sensing is a current buzzword in the realms of cardiac ablation, the outcome of the procedure being somewhat dependent on the quality of contact with tissues. Now device company St. Jude Medical, Inc. has announced the FDA approval of its TactiCath™ Quartz irrigated ablation catheter, which it says gives physicians a real-time, objective measure of the force that the catheter applies to a patient’s heart wall during ablation.

Background

In the U.S., an estimated 2.7 million people are impacted by AF, making the condition the most common type of arrhythmia affecting Americans today.

Being a procedure that is undertaken in the cath lab, physicians have hitherto been limited to estimating by touch with their hands the amount of force applied to the heart wall during an ablation. This clearly introduces an element of variability to proceedings, too little force potentially resulting in too little ablation with the likely recurrence of AF. Contrastingly, if too much force is applied, there is a risk of tissue injury, which can lead to serious procedure-related complications.

The TactiCath Quartz ablation catheter provides electrophysiologists the ability to monitor the amount of pressure that a catheter tip exerts on the endocardium.

Contact force data produced by the catheter is displayed on the EnSite Velocity System, a cardiac mapping and navigation system (pictured), which seamlessly integrates contact-force ablation technology and 3-D mapping and navigation capabilities. This allows for straightforward integration of TactiCath Quartz and contact force technology in existing St. Jude Medical accounts with little impact to the physician workflow or electrophysiology lab footprint.

Physician comments

“The number of patients with atrial fibrillation is growing rapidly in the U.S.,” said Dr. Vivek Reddy, director of electrophysiology at Mount Sinai Hospital, N.Y. “As the number of patients impacted by this disease continues to grow, it is important to develop treatment solutions that increase the efficiency and effectiveness of ablation therapies. TactiCath Quartz is an important advancement that provides critical information during ablation procedures.”

Company comments

“St. Jude Medical has a long history of introducing leading ablation technologies to the electrophysiology community,” said Eric S. Fain, M.D., group president of St. Jude Medical. “This approval speaks to our commitment to investing in and developing world class, cost-effective solutions that are backed by clinical evidence in order to improve the quality of care for millions of patients impacted by atrial fibrillation.”

Source: St. Jude Medical Inc., Business Wire

 

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