GENEVA--(BUSINESS WIRE)--Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has reported another year of significant advancement in the move toward making contact-force sensing a standard of care in catheter ablation procedures. Participating at the Heart Rhythm 2012 meeting in Boston, May 9 – 12, the company noted a wealth of new clinical abstracts and a new HRS/EHRA/ECAS consensus statement as key validation points supporting the value of the sensory parameter in cardiac ablation.
Among the clinical data presented at Heart Rhythm 2012 were more than 20 abstracts exploring the use of contact-force sensing during catheter ablation procedures; these abstracts build on more than 50 clinical papers and presentations on the subject since 2010 alone. Fourteen of the new Heart Rhythm 2012 abstracts featured Endosense’s TactiCath, the first force-sensing catheter to give the electrophysiologist a real-time, objective measure of contact force during the catheter ablation procedure.
Key new data on the TactiCath included the results of Endosense’s EFFICAS II clinical study, presented by Dr. Josef Kautzner (Prague, Czech Republic) in “Contact Force, FTI™ [Force Time Integral] and Lesion Continuity Are Critical to Improve Durable PV Isolation: EFFICAS II Results.” The data showed that contiguous lesions created following the Contact Force Guidelines identified in EFFICAS I (CF above 10g and FTI above 400gs) resulted in superior ablation outcomes, with durable pulmonary vein isolation of up to 98 percent found at three months via invasive follow-up. Several other studies presented showed the importance of FTI as a determinant for ablation success or for a reduction of procedure time.
Additional force sensing-related topics discussed at the Heart Rhythm meeting include the 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, which was released in March. For the first time, the consensus statement recognizes contact-force sensing as a parameter that has the potential to improve the efficacy and safety of catheter ablation procedures.
“The field of contact-force sensing is clearly experiencing tremendous momentum, as more and more scientific evidence and clinical use point to its value in improving outcomes and shortening procedure times of catheter ablation procedures,” said Jan Keltjens, Endosense president and chief executive officer. “Endosense is proud to have pioneered the concept of contact-force sensing in catheter ablation and to have also validated it with the groundbreaking TOCCATA and EFFICAS studies, and we are very pleased to remain at the forefront of this exciting field today.”
Endosense’s leadership in the field of contact-force sensing dates back to the first abstract on the TactiCath at Heart Rhythm 2006. Since that time, the company has conducted a number of clinical studies demonstrating the safety and effectiveness of contact-force sensing over traditional ablation technologies, and has also nearly completed enrollment in the pivotal TOCCASTAR investigational device exemption clinical trial.
About Endosense
Founded in Geneva in 2003, Endosense is a medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias. The company pioneered the use of contact-force measurement in catheter ablation with the development of 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.
Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.