BIOTRONIK SE Co. & KG highlights two key milestones toward receiving premarket approval (PMA) of the TactiCath, a novel technology for treating atrial fibrillation (AF): FDA IDE (investigational device exemption) approval and the first patient enrollment of the TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) clinical trial.
“The unique TactiCath technology provides physicians with objective measures of contact force—reliably and in real-time”
TactiCath is an irrigated radio frequency (RF) contact force ablation catheter. Since January 2010, commercialization efforts have led to significant appreciation of the advantages of contact force-sensing by the electrophysiology community. BIOTRONIK is proud to partner with the TactiCath manufacturer, Endosense, as the exclusive distributor for all major markets outside of the United States, Japan and Asia.
A major challenge that physicians face when they treat patients with AF is manipulating the ablation catheter in the highly variable anatomy of the left heart with precisely the right amount of force to effectively ablate cardiac tissue without causing damage.
"The unique TactiCath technology provides physicians with objective measures of contact force—reliably and in real-time," commented Marlou Janssen, Global Vice President of Marketing and Sales at BIOTRONIK. "Early clinical data suggests it helps to reduce redo procedures in AF ablation, which would subsequently lead to improved efficacy, safety and reproducibility of the therapy."