Endosense and BIOTRONIK Announce CE Mark Approval, First Clinical Use of the New TactiCath(R) Quartz Force-Sensing Ablation Catheter
JUN 12, 2012 - 08:50 ET
FOR: BIOTRONIK SE. CO. KG
GENEVA and BERLIN--(Marketwire - June 12, 2012) - Endosense and BIOTRONIK SE & Co. KG have announced that Endosense's TactiCath® Quartz force-sensing ablation catheter has been CE mark approved in Europe. First cases using the new device have been performed by renowned physicians at three centers across Europe: Dr. D. Shah from University Hospital of Geneva, Dr. G. Nölker from Heart and Diabetes Center in Bad Oeynhausen, Dr. R. Wakili and Dr. H. 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 pre-procedure calibration; a small equipment footprint for easier lab integration; 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 a long-time user of the TactiCath®, I find the Quartz generation to be another significant improvement in the field," said Dr. Shah. "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."
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 TactiCath® Quartz is an innovation born from more than two years of extensive commercial experience with earlier TactiCath® devices; Endosense believes this third generation device will set the new standard in the field.
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.
About BIOTRONIK SE & Co. KG
Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.
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