Endosense launches study of its TactiCath ablation catheter
This article was originally published in Clinica
Swiss firm Endosense has enrolled the first of 300 patients in the TOCCASTAR clinical study, assessing the TactiCath contact force ablation catheter in the treatment of symptomatic paroxysmal atrial fibrillation (AF). The prospective, randomised, investigational device exemption (IDE) trial is designed to evaluate the effectiveness and safety of TactiCath compared with an approved catheter. Results will be used to support a premarket approval (PMA) application to the US FDA for the TactiCath catheter and accompanying TactiSys system. Geneva-based Endosense launched the catheter outside the US in April 2010; Biotronik is its exclusive distributor in Europe, Latin America, Canada, Africa and the Middle East.