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 announced the European launch of the
TactiCath 75 force-sensing ablation catheter 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. 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.
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. 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