EndoSense said it’s logged the 1st use of its TactiCath Quartz contact-force sensing ablation catheter in a new arm of its Toccastar trial of the device.
The TactiCath Quartz uses a force sensor to indicate whether the ablation catheter, used to treat cardiac arrhythmias, is in contact with the portion of the heart muscle to be ablated.
The TactiCath Quartz device won CE Mark approval in the European Union last year.*
"The TactiCath Quartz brings several technical and functional advancements to the electrophysiology lab that further strengthen our leadership position in the field," chairman, president & CEO Jan Keltjens said in prepared remarks. "Its use in the TOCCASTAR Supplemental Clinical Study will pave the way for us to continue to offer electrophysiologists and their patients the most advanced contact-force sensing technology available, once we achieve anticipated approval in the United States."
EndoSense said it hopes to file for pre-market approval from the FDA during the 4th quarter of this year, backed by data from the Toccastar trial.
*Correction, Feb. 6, 2013: This article originally stated that EndoSense launched a new U.S. trial. Return to the corrected sentence.
