Endosense Announces CE Mark Approval, First Clinical Use of the New TactiCath® Quartz Force-Sensing Ablation Catheter

GENEVA--(BUSINESS WIRE)--Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, 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 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.

“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.”

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.

“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 LSI will be available in addition to the already widely recognized FTI (Force Time Integral) feature, also developed by Endosense.

“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.”

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

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

About Endosense

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 force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Endosense is backed by Edmond de Rothschild Investment Partners, Neomed, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners and Initiative Capital Romandie. For more information, visit www.endosense.com.

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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