BERLIN – BIOTRONIK SE Co. & KG is proud to announce that the final results of the AURUM 8 clinical trial have been published in EP-Europace, an official journal of the European Society of Cardiology and the European Heart Rhythm Association.
Atrial flutter is often seen comorbidly with atrial fibrillation (AF), and is the second most common tachyarrhythmia, or rapid heart beat disorder, after AF. Atrial flutter is a condition for which there are 200,000 new incidences of affected people in the United States annually. With an enrollment of 463 patients, AURUM 8 was the world’s largest international randomized controlled trial to study the ablation of typical atrial flutter and the use of gold-tip versus platinum-iridium-tip ablation catheters.
“AURUM 8 has shown that for typical atrial flutter, gold-tip catheters result in a higher ablation treatment success rate,” commented Thorsten Lewalter, head of Cardiology at Marien-Hospital Bonn and Professor of Medicine at the University of Bonn, located in Bonn, Germany. “Gold-tip ablation catheter technology significantly reduces the rate of charring and coagulum formation, which is a marker for increased safety for the patients."
In conventional procedures to ablate typical atrial flutter, almost 5% of catheters have to be exchanged to complete the treatment. In AURUM 8, for every gold-tip catheter exchanged, a ratio of 10 control catheters were exchanged, meaning that with BIOTRONIK’s unique gold-tip technology, catheter exchange due to charring and coagulum was virtually eliminated. This reduces the risk to patients and decreases costs for the hospital.
“At BIOTRONIK we deliver clinical excellence by supporting research that explores the industry’s most challenging questions,” commented Marlou Janssen, Global Vice President of Marketing & Sales at BIOTRONIK. “Catheter ablation for atrial fibrillation and atrial flutter are currently high-volume procedures. We have developed gold-tip technology to increase therapy effectiveness as well as decrease procedural costs, and the achievement of these goals is now proven with AURUM 8.”
In addition to the AURUM 8 results, Professor Hiroshi Nakagawa from the University of Oklahoma has substantiated the superiority of gold-tip ablation technology. In 2009, he published an abstract in Circulation regarding thrombus rates experienced with irrigated gold-tip catheters, and indicated that the benefit of significantly decreased thrombus clearly increases patient safety compared with conventional irrigated catheters in left-sided AF ablation therapy.
To view the entire AURUM 8 results article, visit:
To view the Nakagawa abstract, visit:
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 more than 100 countries by its global workforce of over 5,400 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.