Healthcare Industry News: arrhythmia
News Release - May 13, 2010
Endosense Announces 12-Month TOCCATA Study Data Reinforcing Clinical Benefit of the TactiCath(R)
GENEVA--(HSMN NewsFeed)--Endosense, a medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has announced the release of 12-month data from the TOCCATA (TOuCh+ for CATheter Ablation) study that further reinforce the potential of the TactiCath force-sensing ablation catheter to improve clinical outcomes in the treatment of cardiac arrhythmia by catheter ablation. The data was reported in a clinical abstract at Heart Rhythm 2010, the Heart Rhythm Society’s 31st Annual Scientific Sessions in Denver, May 12 – 15.Led by Principal Investigator Karl-Heinz Kuck, M.D., with the participation of 21 additional highly experienced 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.”
About the TactiCath
Endosense’s TactiCath is the first and only force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. It has undergone considerable pre-clinical and clinical validation, the results of which have created a solid foundation of evidence supporting the feasibility, safety and value of contact force sensing during catheter ablation. The TactiCath has the potential to improve the effectiveness, safety and reproducibility of catheter ablation treatment of cardiac rhythm disorders, including AF.
Granted CE mark in 2009, the TactiCath and its TactiSys™ supporting system are indicated for the treatment of atrial fibrillation and supraventricular tachycardia.
BIOTRONIK is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the United States.
About Endosense
Founded in Geneva in 2003, Endosense is a medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias. The company has pioneered the use of contact force measurement in catheter ablation, with the development of its proprietary Touch+® sensor technology. Endosense’s flagship product is the TactiCath, the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure.
Endosense is backed by Edmond de Rothschild Investment Partners, Neomed, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners and Initiative Capital Romandie. For more information, visit www.endosense.com.
Source: Endosense
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