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BIOTRONIK Receives European Approval For TRIGNUM Flux Magnetic Irrigated Gold Tip Catheter

BIOTRONIK has announced the CE mark approval and completion of the first successful cardiac ablation clinical case with the TRIGNUM Flux magnetic irrigated gold tip catheter. The launch of the TRIGNUM Flux catheter represents an important introduction of unique, novel technology for the treatment of Atrial Fibrillation, and represents another solid block in the foundation of the rapidly growing EP business unit that BIOTRONIK is building. 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. 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 during the “Expert Meeting Berlin”. 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. After the first successful clinical procedure Prof. Kuck commented on the TRIGNUM Flux: “With the caution of a scientist I can say that I am quite enthusiastic about the performance of the TRIGNUM Flux catheter. It has superior steerability and stability in different anatomical locations on the right and left side of the heart and we have not seen any kind of blood clotting during the case. The TRIGNUM Flux combines safety and efficacy in a unique way.” "We are very excited about the commercial release of the TRIGNUM Flux magnetic irrigated gold tip catheter” commented Marlou Janssen, Global Vice President Marketing & Sales CRM of BIOTRONIK GmbH & Co. KG.