On 1 February, Endosense announced that its new generation TactiCath Quartz contact-force sensing ablation catheter has been used for the first time in the United States by J Michael Mangrum at University of Virginia Medical Center in Charlottesville.
The first US case was performed on 31 January 2013 as part of an amended protocol of the company’s TOCCASTAR investigational device exemption clinical study of the TactiCath called the TOCCASTAR Supplemental Clinical Study. According to a company release, the supplemental study’s protocol is identical to that of original TOCCASTAR study, with the exception that the patients treated with the newer device will not be randomised.
“The TactiCath Quartz features several enhancements that have improved my ability to leverage contact-forcing sensing during the catheter ablation procedure,” said Mangrum. “I believe that the device represents another step forward for this exciting technology that, should it ultimately prove to be safe and effective, has the potential to become the gold standard in the catheter ablation treatment of cardiac arrhythmias.”
The TactiCath Quartz, which received CE mark approval in June 2012 and was launched commercially in Europe by Endosense in December 2012, features a new force sensor that provides increased stability and precision and avoids the need for pre-procedure calibration; a significantly smaller equipment footprint; a user friendly graphical interface; and enhanced signal processing and digital output that facilitates connectivity with imaging devices and other equipment in the lab.
As announced by the company on 13 June 2012, Endosense has completed enrolment in the original TOCCASTAR IDE clinical study. The company expects to use the results of the study to file a premarket approval application to the FDA in the fourth quarter of 2013.