First US Patient For Endosense TactiCath® Quartz Contact-Force Sensing Ablation Catheter

In short

Endosense has announced that its new generation TactiCath Quartz contact-force sensing ablation catheter has been used for the first time in the United States.

The company is a pioneer and leader in contact-force sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias.

Background

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 such catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure.

The TactiCath Quartz received CE mark approval in June 2012 and was launched commercially in Europe by Endosense in December 2012.  Endosense says it 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.

The first U.S. case for Quartz was performed on January 31 as part of an amended protocol of the company’s TOCCASTAR IDE clinical study of the TactiCath (called the “TOCCASTAR Supplemental 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.

 Physician comments

Dr. J. Michael Mangrum at University of Virginia Medical Center in Charlottesville, Va, commented; “The TactiCath Quartz features several enhancements that have improved my ability to leverage contact-forcing sensing during the catheter ablation procedure. 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.”

Company comments

“The TactiCath Quartz brings several technical and functional advancements to the electrophysiology lab that further strengthen our leadership position in the field,” said Jan Keltjens, president, chief executive officer and chairman of Endosense. “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.”

Regulatory status

In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.

Source: Endosense, Inc., Business Wire