Berlin, May 10, 2010 - BIOTRONIK SE & Co. KG, a leading manufacturer of implantable cardiac devices and pioneer of remote monitoring technologies today announced the market release of the TactiCath catheter. The TactiCath catheter, an Endosense company product, is an irrigated RF contact force ablation catheter with features that offer a major advance in ablation therapy for patients with cardiac arrhythmias and particularly Atrial Fibrillation (AF).
BIOTRONIK successfully initiated the TactiCath launch with simultaneous cases at leading heart centers across Europe, including Professor Richard Schilling at St. Bartholomew’s Hospital, London UK, Dr. Juergen Schreieck, University of Tuebingen and Professor Dipen Shah, HUG Geneva.
“On the occasion of the 3rd International Advanced Workshop for Atrial Fibrillation we performed two successful live case transmissions using the TactiCath”, commented Professor Schilling. “The ability to sense contact force will shift the paradigm of how electrophysiologists plan and execute ablation therapies; the potential for improved patient outcomes is very exciting.” Dr. Schreieck added, “This new technology is truly a milestone in electrophysiology. It is impressive to see the impact of contact force information on the ablation procedure. Having this tool available to ensure reliable and consistent RF application has the potential to reduce the unacceptably high redo rate in AF ablation”.
A major challenge that physicians face when they treat patients with AF is manipulating the ablation catheter in the highly variable anatomy of the left heart with precisely the right amount of pressure to effectively ablate cardiac tissue without causing damage. The new TactiCath is the first commercially available irrigated force-sensing RF ablation catheter that can provide physicians with objective measures of contact force, reliably and in real-time. This technology has the potential to dramatically change clinical practice, and lead to improved efficacy, safety and reproducibility of catheter ablation procedures.
The TactiCath is a second generation device, with a solid scientific background established by the excellent results of its preclinical and clinical research program. The TOCCATA clinical trial, upon which CE mark was granted, established safety and effective performance of the device and has shown that contact force varies significantly from operator to operator and from ablation site to ablation site. It has raised the expectation that contact force technology has the potential to improve the outcome of AF ablation procedures. Beginning in May, Endosense’s EFFICAS study series will be initiated, with the intention to demonstrate that the use of contact force control during cardiac ablation utilizing the TactiCath force-sensing catheter results in superior outcomes as compared to ablations performed without force sensing.
Additionally, the ProFORCE registry will begin upon launch and will provide robust post-market surveillance with observational data of up to 2000 patients treated with the TactiCath catheter, and will study the use and impact of contact force monitoring during catheter ablation.
“AF ablation is a key strategic focus of BIOTRONIK,” commented Marlou Janssen, Global Vice President of Marketing and Sales. “We have demonstrated our continued commitment to further build the EP franchise, by securing the exclusive distribution rights of the second generation TactiCath in all major markets outside the United States, Japan and Asia. The TactiCath complements an already robust portfolio of ablation and diagnostic catheters, surrounded by comprehensive customer education and an International Fellows Program.”
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 5,100 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.
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