Healthcare Industry News:  Magnetic Navigation 

Devices Cardiology Regulatory

 News Release - February 11, 2009

BIOTRONIK Announces CE Mark and First Successful Clinical Case with TRIGNUM Flux Magnetic Irrigated Gold Tip Catheter

BERLIN--(HSMN NewsFeed)--BIOTRONIK, a leading European medical technology company focusing on vascular intervention and cardiac rhythm management, announces the CE mark 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, new 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.

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.

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. “Making the safety profile of our irrigated gold tip ablation catheters available for Magnetic Navigation will result in a significant increase of adoption for this breakthrough technology. More patients with complex cardiac rhythm disorders can be safely treated. AF is a clear strategic focus for BIOTRONIK with ablation being a therapy solution. We have strengthened our commitment to this technology with the acquisition of Vascomed last year and we are delivering on our commitment with the launch of six new products this year.”


As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4000 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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