EP Lab Digest - January 2008 - (Page 41) JANUARY 2008 NEWS 41 Sorin Group Cardiac Rhythm Management Announces the First U.S. Enrollment in the OPTION Study The OPTION Study is Evaluating the Clinical Outcome of ICD Patients with Dual-Chamber Arrhythmia Detection and Minimized Ventricular Pacing, Compared to SingleChamber Operation Continued from page 1 PTION is a global, multi-center, prospective, single-blinded, two-arm randomized trial. It evaluates ICDs with dual-chamber pacing and arrhythmia detection with therapy enabled for slow ventricular tachyarrhythmias in comparison to ICDs with single-chamber pacing and tachyarrhythmia detection with therapy disabled for slow ventricular tachyarrhythmias. Sorin Group's Ovatio™ DR 6550 ICD has specific arrhythmia detection algorithms, PARAD and PARAD+™ (P and R Based Arrhythmia Detection). It also has Sorin Group's pacing algorithm to minimize ventricular pacing, AAIsafeR™. Additionally, it has a slow ventricular tachycardia zone, BTO™ (Brady-Tachy Overlap), which is designed to “Unlock Pacing and Detection,” allowing bradycardia pacing in the slowVT zone. O “There is a need to continue to develop, evaluate, and utilize effective therapies and advanced algorithms in optimizing treatment and managing ICD patients. The OPTION study assesses these advanced features and outcomes. More data are needed for understanding the incidence and long-term effects of untreated slow VT in the general ICD population,” commented Dr. Dan. Ovatio™ DR's BTO™ feature offers flexible programming for detection and treatment of slow VT while also providing bradycardia pacing support when needed.The incidence of slow VT, and the incidence of access to the health care system due to slow VT, will be reported during this study. The OPTION study will enroll 450 patients in the United States, Europe, and Asia. Some 150 patients have already been enrolled in the study. University Hospital of Bordeaux Officially Opens New Electrophysiology Lab tereotaxis, Inc. announced the official opening of the Stereotaxis Magnetic Navigation System at the new electrophysiology (EP) lab at the University Hospital of Bordeaux, France. The lab is headed by Professors Michel Haissaguerre and Pierre Jais, whose discovery of the ectopic foci that trigger atrial fibrillation (AF) in 1998 paved the way for new ablation techniques for more effectively treating this disease, which affects millions of people worldwide. The new EP lab was unveiled in a ceremony at which Alain Heriaud, General Director of CHU of Bordeaux, Bevil Hogg, CEO of Stereotaxis and Alain Juppe, Mayor of Bordeaux and president of the board of directors of CHU of Bordeaux, presided. "We are very enthusiastic about the present and future applications for the Stereotaxis system, which represents an engineering tour de force," said Professor Haissaguerre. "The Stereotaxis system allows stable and precise catheter positioning potentially better than manual manipulation. Our initial experience on atrial fibrillation using the magnetic irrigated catheter is very promising, suggesting notably the potential for a higher safety margin in comparison with conventional manipulation while maintaining at least equivalent efficacy." S "Our next goal is to achieve complete automation of the many different techniques necessary for catheter ablation of cardiac arrhythmias and particularly atrial fibrillation. We hope our partnership with Stereotaxis will be mutually beneficial in achieving our goals of further understanding and treating the most complex rhythm disturbances leading to better patient care," Professor Haissaguerre concluded. "The installation of the Stereotaxis Niobe® system in Bordeaux represents a significant milestone for us, and we are particularly honored that the system has been installed at the University Hospital of Bordeaux, one of the leading research institutions in the world for electrophysiology," said Bevil Hogg, CEO of Stereotaxis. "We are also proud to note that Bordeaux has installed the Stereotaxis system with an Odyssey™ Network Solution. Odyssey is a powerful fully-networked user interface that consolidates the multiple information sources and systems of a traditional electrophysiology lab into one large screen with single mouse control, and has the potential to contribute significantly to procedure room simplification and work-flow productivity, and through its private network, to promote the dissemination of best practices worldwide."
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