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FDA approves contact force-sensing ablation catheter

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St. Jude Medical Inc. announced that it has received FDA approval for an irrigated ablation catheter for the treatment of atrial fibrillation.

The TactiCath Quartz contact force ablation catheter is intended to allow greater control over the amount of force applied to the heart wall during ablation for paroxysmal AF, resulting in the creation of more effective lesions, according to a press release.

The catheter features force-sensing technology that monitors the pressure exerted on the endocardium by the tip of the device. The approval follows results from several studies, including TOCCATA, EFFICAS I and EFFICAS II, indicating reduced risk for recurrence of AF with the use of optimal contact force. In the TOCCASTAR trial, patients with paroxysmal AF treated with TactiCath were free of recurrence at 12 months in 85.5% of cases when optimal contact-force parameters were achieved, compared with 67.7% of those in which non-optimal parameters were used, according to the release.

Vivek Y. Reddy

“The number of patients with AF is growing rapidly in the US,” Vivek Y. Reddy, MD, director of electrophysiology at Mount Sinai Hospital in New York, said in the release. “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.”