The FDA approved St. Jude Medical’s contact-force ablation catheter for treating patients with atrial fibrillation.
The approval paves the way for electrophysiologists to use the TactiCath Quartz irrigated ablation catheter, which allows them to gauge the amount of force applied during ablation procedures. Approval was based on clinical trial data that showed the TactiCath technology reduced the rate of recurrence of atrial fibrillation. In the TOCCASTAR trial, 85.5 percent of patients who were treated with the contact-force technology remained free of paroxysmal atrial fibrillation at 12 months when operators achieved the optimal contact-force parameters.
St. Jude added the technology to its portfolio in 2013 with the acquisition of Endosense SA. St. Jude paid $170 million for the company with $161 million to be forthcoming if the company met regulatory milestones within a designated timeframe.
The force-sensing ablation catheters received CE mark in Europe for treating supra ventricular tachycardia in 2009.
According to St. Jude, the contact force data can be displayed on its EnSite Velocity System, a cardiac mapping and navigation system through a designated module. The software module is FDA cleared and CE mark approved.