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Biotronik wins CE Mark for Trignum Flux catheter

Biotronik, a medical technology company, has announced the CE Mark and completion of the first successful cardiac ablation clinical case with the Trignum Flux magnetic irrigated gold tip catheter.

The first clinical case was successfully performed by Karl-Heinz Kuck, director of the cardiologic center at the Asklepios Klinik in Hamburg, Germany, said Biotronik. 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, according to Biotronik. Its complementary flexibility combined with the computer-aided magnetic-guided Stereotaxis Niobe System reportedly 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, the company added.

Marlou Janssen, global vice president of marketing and sales CRM of Biotronik, said: 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.

Atrial fibrillation 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 in 2008 and we are delivering on our commitment with the launch of six new products in 2009.