Endosense announced the European launch of the TactiCath 75 force-sensing ablation catheter for the treatment of atrial fibrillation as well as results of the EFFICAS clinical study of contact force-sensing in catheter ablation procedures.
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.
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, multicentre European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation, gap formation at three months, and atrial fibrillation 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 pulmonary vein isolation lines. Contact force parameters from initial procedures were then analysed to determine the relationship with lesion formation.
According to Neuzil P et al, 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. 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.
The TactiCath 75 is now offered commercially in Europe through Endosense’s distribution partner Biotronik and is expected to be available soon for use in the TOCCASTAR US investigational device exemption (IDE) study of the TactiCath.
In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.