Endosense Launches TactiCath 75 Force-Sensing Catheter, Announces New Results of EFFICAS I Clinical Study
The TactiCath 75 is an 8.5 F sheath compatible, state-of-the-art open irrigated, steerable radiofrequency ablation catheter that employs the same proprietary force-sensing technology as the original TactiCath but features a longer, 75 millimeter curved tip. With the availability of both curve diameters, electrophysiologists can now address the vast majority of patient anatomies in the catheter ablation treatment of atrial fibrillation (AF). The TactiCath 75 is now offered commercially in Europe through Endosenses distribution partner BIOTRONIK and is expected to be available soon for use in the TOCCASTAR U.S. investigational device exemption (IDE) study of the TactiCath.
In addition, Endosense has unveiled new results from its EFFICAS I European post-market study. The first in a series, EFFICAS I is a 46-patient, single-arm, prospective, multi-center European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation (PVI), gap formation at three months, and atrial fibrillation (AF) treatment efficacy. While investigators performed the procedure with the TactiCath, they were blinded to contact force measurements; however, the contact forces applied were recorded. Patients were re-assessed with a mapping catheter at three months to identify potential gaps in the PVI lines. Contact force parameters from initial procedures were then analyzed to determine the relationship with lesion formation.
The new EFFICAS results have shown that the creation of a continuous line of ablation points performed with a minimum force of 10 grams and a minimum Force-Time Integral (FTI™) of 400 gram seconds provides significantly higher success rate in electrical isolation per pulmonary vein segment.1 These minimum force and FTI parameters are the guidelines that were followed in the EFFICAS II clinical study, in which investigators took full advantage of the real-time, objective TactiCath contact-force control features to improve their ablation technique during lesion creation.
"The new findings from EFFICAS continue to demonstrate the clear value of contact-force sensing in catheter ablation procedures, as they prove that electrical reconnections caused by inadequate, non-transmural lesions can be avoided with the use force and FTI information," said Jan Keltjens, Endosense president and chief executive officer. "Equally exciting are the suggested contact-force parameters for optimal lesion formation, which we have evaluated in EFFICAS II. These and other studies are key elements in our commitment to evidence-based medicine and establishing force sensing as part of the future standard of care."
The EFFICAS II study was completed in October 2011, and Endosense expects to announce its results in the first half of 2012.
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. Launched in April 2010 with a full release in September 2010, the second generation of the novel device has been used across Europe to treat more than 1,500 patient cases of atrial fibrillation (AF) and supraventricular tachycardia (SVT). Endosense is currently conducting several post-market clinical studies aimed at proving the superiority of the TactiCath force-sensing catheter over standard irrigated catheters, as well as the TOCCASTAR investigational device exemption (IDE) clinical trial.
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.
1 Neuzil, P, et al., "EFFICAS I Results – Are Low Contact Force Parameters Predictors for Gap Formation after Pulmonary Vein Isolation by Radiofrequency Catheter Ablation?" AHA abstract No. 18101, AHA 2011, Orlando, USA
Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.
Posted by Sean Fenske, Editor-in-Chief, MDT