Endosense extends catheter ablation options; EFFICAS postmarketing data emerges
Endosense has begun the European release of the TactiCath 75 force-sensing ablation catheter, and released data from the company's EFFICAS study of contact force-sensing in catheter ablation procedures.
The TactiCath 75 is an 8.5 Fr sheath compatible, open irrigated, steerable radiofrequency ablation catheter that employs the same force-sensing technology as the original TactiCath, but features a longer, 75 mm curved tip. With the availability of both curve diameters, Endosense believes that electrophysiologists will be able to address the vast majority of patient anatomies in the catheter ablation treatment of atrial fibrillation (AF). The TactiCath 75 is being made available in Europe through Endosenseâs distribution partner Biotronik and is expected to be available for use in the TOCCASTAR US IDE study of the TactiCath.
In addition, Endosense has unveiled data from its EFFICAS I European post-market study. The first in a series, EFFICAS I is a 46-patient, single-arm, prospective, multi-centre European trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation (PVI), gap formation at three months and AF treatment efficacy. While investigators performed the procedure with the TactiCath, they were blinded to contact force measurements, with the contact forces applied and 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 analysed to determine the relationship with lesion formation.
The EFFICAS data have shown that the creation of a continuous line of ablation points performed with a minimum force of 10g and a minimum Force-Time Integral (FTI) of 400g/s provides significantly higher success rate in electrical isolation per pulmonary vein segment. These minimum force and FTI parameters are the guidelines that were followed in the EFFICAS II 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 EFFICAS II study was completed in October 2011, and the company expects to release its results in the first half of 2012.