News | June 18, 2012

Endosense Announces CE Mark, First Use of the Tacticath Quartz Force-Sensing Ablation Catheter

June 18, 2012 — Endosense announced its TactiCath Quartz force-sensing ablation catheter has been CE mark approved for use in Europe. In cooperation with the company’s distributor Biotronik, first cases using the new device have been performed by renowned physicians at three centers across Europe: Dr. Dipen Shah from University Hospital of Geneva; Dr. Georg Nölker from Heart and Diabetes Center in Bad Oeynhausen, Germany; and, Dr. Reza Wakili and Dr. Heidi Estner from University Hospital Grosshadern in Munich.

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 force time integral (FTI) feature, also developed by Endosense.

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. 

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