The European regulators have just approved a new device designed for the treatment of atrial fibrillation by cardiac electrophysiologists in cath labs. BIOTRONIK reports that it has received the CE mark for its new TRIGNUM Flux magnetic irrigated gold tip catheter. With guidance provided by Stereotaxis, the first use of the catheter was recently completed in Germany. (See Stereotaxis flashbacks below.)
From the press statement by BIOTRONIK:
The first clinical case was successfully performed by Prof. Dr. Karl-Heinz Kuck, Director of the Cardiologic Center at the Asklepios Klinik in Hamburg, Germany. During this case a patient who presented with a comorbidity of Atrial Fibrillation and Atrial Flutter was successfully mapped and ablated in both atrial chambers of the heart.
What makes the TRIGNUM Flux so special? The TRIGNUM Flux magnetic irrigated gold tip catheter is a highly flexible ablation device equipped with three magnets at the distal end. Its complementary flexibility combined with the computer-aided magnetic-guided Stereotaxis Niobe® System ensures a precise, stable, sensitive and reproducible catheter positioning. The safety of the device is further enhanced by the catheter’s unique irrigated gold tip electrode with high thermal conductivity. This feature prevents thrombus formation, commonly known as blood clotting, during the ablation procedure and could enable safer procedures with better outcomes.
The superiority of the irrigated gold tip ablation concept was recently highlighted by Prof. Hiroshi Nakagawa, Co-Director of the Heart Rhythm Institute, University of Oklahoma Health Sciences Center (Oklahoma, USA) during the “Expert Meeting Berlin” on January 30th, 2009. In his scientific validation Prof. Nakagawa demonstrated that irrigated gold tip ablation reduces the incidence of thrombus formation significantly compared to conventional irrigated ablation technology.
Press release: BIOTRONIK Announces CE Mark and First Successful Clinical Case with TRIGNUM Flux Magnetic Irrigated Gold Tip Catheter
Flashbacks: Stereotaxis; Stereotaxis Zaps Atrial Fibrillation All Right ; Stereotaxis Magnetic RF Guidewire Gets FDA OK; Philips and Stereotaxis: Joystick Precision for Complicated Caths