Endosense announces 12-month TOCCATA study data reinforcing clinical benefit of the Tacticath
Led by Principal Investigator Karl-Heinz Kuck, M.D., with the participation of 21 additional investigators, TOCCATA was an eight-center, prospective study designed to evaluate the safety and effective performance of the TactiCath. Investigators used the TactiCath to perform catheter ablations on 76 patients, including 34 with paroxysmal atrial fibrillation. Primary safety and performance endpoints were met during the course of the study.
In the new data presented during Heart Rhythm 2010, TOCCATA abstract authors suggested room for a safer and more effective catheter ablation treatment in the future, as retrospective analysis identified a statistically significant relationship (p<0.05) between the contact force applied at ablation sites and the 12-month success of the procedure (median contact force applied in the non-recurrent patient group was 20g versus 11g in the recurrent patient group).
“The 12-month results offer a very promising perspective on the TactiCath’s ability to improve clinical outcomes in the catheter ablation treatment of cardiac arrhythmias,” said Eric Le Royer, Endosense president and chief executive officer. “Endosense was founded to help physicians and patients realize the great potential of safe and effective catheter ablation, and we continue to deliver on that mission with this remarkable and unique data. Building on the success of TOCCATA, we are supporting the launch of several, additional groundbreaking studies over the course of 2010, a move that further reinforces Endosense’s leadership position in the field.”
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