First U.S. Case Performed with Endosense’s Ablation Catheter

The first U.S. case was performed by Dr. J. Michael Mangrum at University of Virginia Medical Center on January 31 as part of an clinical study of the TactiCath (called the "TOCCASTAR Supplemental Clinical Study"). 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 randomized.
 
“The TactiCath Quartz features several enhancements that have improved my ability to leverage contact-forcing sensing during the catheter ablation procedure,” said Dr. 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, offers several key innovations over the previous TactiCath model. The device 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 on June 13, 2012, Endosense has completed enrollment in the original TOCCASTAR IDE clinical study. The company expects to use the results of the study to file a Premarket Approval (PMA) application to the U.S. Food and Drug Administration in the fourth quarter of 2013.
 
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.