EP Lab Digest - February 2008 - (Page 37)

FEBRUARY 2008 NEWS 37 Boston Scientific Announces CE Mark Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death Continued from page 1 hen choosing a high-energy device, physicians often must make trade-offs among device size, battery longevity and features.The COGNIS CRT-D and the TELIGEN ICD are designed to eliminate those compromises. They are among the smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on significant engineering advances, including extended battery longevity, self-correcting software and improved programming technology. Both devices also offer SafetyCore™, a feature that in the unlikely event of a system error provides lifesaving shock therapy and basic pacing functionality. Key features of the COGNIS CRT-D include: • SmartDelay™: quickly proposes programmable device settings, which enables physicians to tailor individualized pacing therapy for their patients • Bi-V Trigger: helps physicians manage heart failure patients with frequent atrial arrhythmias • Electronic Repositioning™: provides physicians with six configurations for stimulating the left side of the heart even after implant, which may help avoid an W additional surgical procedure. Key features of the TELIGEN ICD include: • Thin device, designed with patient comfort in mind • Reverse Mode Switch™: designed to eliminate unnecessary ventricular pacing • Quick Convert™: provides the ability for patients to receive pacing therapy for ventricular tachycardias "Our CRM team is refocused on delivering therapy systems that meet clinician needs for safety, reliability and better patient outcomes," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We have re-engineered the way we design, build, test and report on our technology." The first COGNIS and TELIGEN implants are scheduled to take place early next month. The company plans to build to a full launch in Europe and other international markets in the second quarter. The COGNIS CRT-D and the TELIGEN ICD are pending approval by the U.S. Food and Drug Administration and are not available for sale in the United States. Clinicians Share Initial Positive Experiences with New Magnetic Irrigated Catheter eading European electrophysiologists shared their initial positive experiences with Stereotaxis' partnered magnetic irrigated catheter, used with its Niobe® Magnetic Navigation System, during the Boston Atrial Fibrillation Symposium, Stereotaxis announced. The new magnetic irrigated catheter is being used by these clinicians with the magnetic navigation system to treat complex arrhythmias, including atrial fibrillation. The new catheter was developed by a partner of Stereotaxis and was launched in Europe in November. The U.S. Food and Drug Administration approved the catheter for mapping and ablation in the United States earlier this month. At the Boston Symposium, several hundred assembled electrophysiologists heard from Prof. Michel Haissaguerre, MD, of the University Hospital of Bordeaux, France; Prof. Gerhard Hendricks, MD, PhD, of Universitat Herzzentrum in Leipzig, Germany; Prof. Karl-Heinz Kuck of AK St. Georg in Hamburg, L Germany; and Prof. Carlo Pappone, MD, PhD of San Raffaele University Hospital in Milan, Italy. Preliminary data was presented from the first 107 procedures performed at 7 institutions using the new magnetic irrigated catheter, of which approximately 68% were to treat paroxysmal atrial fibrillation.Among these 107 cases, 90% acute success was achieved. However, at sites that reported performing more than 20 cases, the acute success rate rose to 95%.There have been no reported complications. In particular, Prof. Haissaguerre described a patient who had suffered with chronic atrial fibrillation for 7 years despite several aggressive therapies, including a prior ablation procedure. He performed an ablation procedure using the Stereotaxis System with the magnetic irrigated catheter and successfully converted the patient into a normal heart rhythm. The patient has not had any recurrence of the arrhythmia since the successful magnetic procedure. “I have been remarkably impressed by the performance of the Stereotaxis partnered magnetic irrigated catheter since the mid-November release in Europe,” said J. David Burkhardt, MD, FACC, and Chief Medical Officer of Stereotaxis. “In comparison with my experience at The Cleveland Clinic with the earlier introduction of the manual irrigated catheter, the safety profile and success rates are outstanding. The magnetic catheter has been able to achieve the difficult endpoints of numerous operators without the need of manual navigation or ablation. Clearly, the initial experience demonstrates the ability for this catheter to replace manual navigation and ablation in very complex arrhythmias.” Bevil Hogg, CEO of Stereotaxis, added, “We are delighted with the initial results of our partnered magnetic irrigated catheter in the treatment of complex arrhythmias, and expect that the European release of this catheter will soon be followed by the establishment of key reference sites in the U.S. using the magnetic irrigated catheter.”

Table of Contents Feed for the Digital Edition of EP Lab Digest - February 2008

EP Lab Digest - February 2008 Creating the U-M Center for Arrhythmia Research: Interview with José Jalife, MD Texas Cardiac Arrhythmia Institute and St. David’s Medical Center Launch State-of-the-Art Training Center Contents Letter from the Editor Spotlight Interview: Caritas St. Elizabeth’s Medical Center 10-Minute Interview: Sue Deck, BS, RN, RCES Keeping Pace With a Blog Roundtable Discussion on Cryoablation Procedures Email Discussion Group: February 2008 Events Calendar Industry News and Products Classifieds Advertisers Index

EP Lab Digest - February 2008

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