CE Mark And First Clinical Use For Endosense TactiCath® Quartz Force-Sensing Ablation Catheter

In short

Endosense has announced that its TactiCath Quartz force-sensing ablation catheter has been CE mark approved. In cooperation with the company’s distributor Biotronik, first cases using the new device have been performed by renowned physicians at three centres across Europe.

Background

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

The TactiCath Quartz is a third generation device that brings a host of technical and practical advancements to the electrophysiology lab. Key innovations include 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.

Also new to the TactiCath Quartz is a breakthrough Lesion Index (LSI) parameter that provides an improved, real-time indication of lesion quality during catheter ablation procedures. Pioneered by Endosense, LSI is a sophisticated algorithm that correlates lesion formation with radiofrequency power, ablation time and contact force.

Clinical data presented at Heart Rhythm 2012 showed that LSI is so far the best available parameter to predict risk for reconnection after pulmonary vein isolation (PVI), with high statistical significance. The LSI will be available in addition to the already widely recognized FTI (Force Time Integral) feature, also developed by Endosense.

Clinician comments

“As a long-time user of the TactiCath, I find the Quartz generation to be another significant improvement in the field,” said Dr. Dipen Shah from the University Hospital of Geneva. “The new force sensor technology gives me even greater confidence in the accuracy of the force signal. In addition, the 50Hz sampling rate dramatically increases precision of the display and gives me every detail of the force applied in real time.”

Company comments 

“The TactiCath Quartz is an innovation born from more than two years of extensive commercial experience with earlier TactiCath devices,” said Jan Keltjens, Endosense president and chief executive officer. “We believe this third generation device will consolidate our leadership position and that LSI will set the new standard in the field. With its greatly enhanced ease of use and performance, the TactiCath Quartz will further advance the strong trend towards force-sensing becoming part of the standard of care.”

Regulatory status

The TactiCath Quartz is CE mark approved for the treatment of atrial fibrillation (AF) and supraventricular tachycardia (SVT). The new device and its accompanying TactiSys system are available commercially in Europe through Endosense’s distribution partner Biotronik.

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

Source: Endosense, Business Wire