Boston Atrial Fibrillation Symposium 2009: News Highlights

Hansen Medical Highlights Sensei Robotic Catheter System Alongside Cohesion 3-D Visualization Module at Boston Atrial Fibrillation Symposium Hansen Medical, Inc. showcased its Sensei® Robotic Catheter System and the CoHesion™ 3-D Visualization Module at the 14th Annual Boston Atrial Fibrillation Symposium, Jan. 15-17, 2009. The integrated EP solution offers physicians a software interface between Hansen Medical's robotic catheter system and St. Jude Medical's EnSite™ System advanced mapping technology. It is designed to provide physicians with 3-D visualization to enhance their ability to move a catheter throughout the heart and is intended to optimize control over catheter placement in specific locations. Gary Restani, president and COO of Hansen Medical, said “We are very encouraged by the broad adoption of our technology worldwide, with 55 systems shipped through 2008 and well over 1,000 clinical cases reported using the Sensei system, many of which have been completed using our integrated solution,” continued Restani. The CoHesion interface expands the utility of the EnSite System and Sensei systems to provide physicians with a comprehensive and easy-to-use remote navigation and mapping system for EP procedures. The EnSite system provides visualization and localization for detection of EP catheters in 3-D space within the heart chamber, while the Sensei system is designed to permit remote movement of catheters in 3-D. By integrating both products, Hansen Medical believes physicians should be able to navigate more instinctively within the 3-D cardiac space because the system enables visualization and catheter movement in 3-D. "The Sensei system with the CoHesion interface is truly innovative because it allows for very accurate catheter manipulation and catheter stability," said Patrick Hranitzky, MD, assistant professor of medicine and director of Clinical Cardiac Electrophysiol-ogy at Duke University Medical Center in Durham, North Carolina. "In addition, the ability to perform complex and potentially long procedures while seated at the workstation without wearing the heavy lead could lead to greater career longevity for clinicians," continued Dr. Hranitzky. St. Jude Medical's EnSite System is an advanced computer-based technology for mapping the electric activity for the heart, and for localizing and visualizing EP catheters in real-time. The EnSite System creates 3-D graphical displays of cardiac structures and arrhythmias, and enables catheter navigation without the use of fluoroscopy. The Sensei system uses flexible medical robotics technology to provide stable and predictable control of catheter movement inside the heart. This technology is designed to provide fine catheter control while mapping in 3-D to enhance the physician's ability to access hard-to-reach anatomy, and to maintain stability during complex cardiac arrhythmia procedures. The physician workstation is adaptable to existing EP lab suites and can be placed away from the field of direct radiation. The disposable Artisan™ Control Catheter is comprised of inner and outer steerable guide catheters that accommodate existing pre-approved percutaneous catheters. And, with the IntelliSense® Fine Force Technology, clinicians have access to real-time measurement and display of the proximal force along the shaft of percutaneous catheters. Unique Bi-Directional Irrigated Tip Cardiac Catheter for Treatment of Irregular Heart Rhythms Now Available in the United States Patients in the United States with arrhythmias may now benefit from treatment with a new state-of-the art catheter designed to reduce char and thrombus formation during ablation and give physicians improved range of motion during procedures to eliminate abnormal heart rhythms. The new EZ STEER® ThermoCool® Bi-Directional Catheter, manufactured by Biosense Webster, Inc., is a unique bi-directional catheter with an open irrigation tip. The U.S. Food and Drug Administration approved the EZ STEER® ThermoCool® Bi-Directional Catheter for marketing in October 2008 and the company announced it is now available throughout the U.S. The approval is for treatment of Type I atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia. Biosense Webster highlighted the EZ STEER® ThermoCool® Bi-Directional Catheter at its booth during the 14th Annual Boston Atrial Fibrillation Symposium. "The addition of a bi-directional ThermoCool® catheter provides all the benefits of open irrigation with the added advantage of enhanced maneuverability to access various areas of the heart with greater ease,” said Emile Daoud, MD, FACC, Professor, Cardiovascular Medicine, Ohio State University Medical Center, Columbus, Ohio, “In addition to bi-directional steering, the EZ STEER® ThermoCool® Bi-Directional Catheter also has greater torque to enhance tissue contact. This catheter is a significant addition." The ThermoCool® Irrigated Tip Catheter technology is designed to maintain safe tip-to-tissue temperatures, ultimately reducing the risk of coagulum and char from high-temperature ablation. To better diagnose and treat certain arrhythmias, the EZ STEER® ThermoCool® Bi-Directional Catheter technology incorporates an ergonomically-inspired handle, a special design that aids comfort and provides the physician with a feeling of “direct connection” with the catheter tip and target ablation area. The EZ STEER® ThermoCool® Bi-Directional Catheter also acts as two curves in one catheter that provides physicians with greater continuity and procedural versatility. Additionally, greater control of power delivery allows the physician to apply the energy needed to create a wider variety of lesion types. When paired with the Stockert RF Generator and the CoolFlow® Pump, specifically designed to support the ThermoCool® Catheter, the supported EZ STEER® ThermoCool® Bi-Directional Catheter is unique for its versatility. Shlomi Nachman, President, Biosense Webster, Inc., said, “Each regulatory approval and product we create to respond to a physician or patient need inspires us to move to the next level in advanced medical care. The new EZ STEER® ThermoCool® Bi-Directional Catheter is a prime example of that inspiration at work.” Dr. Daoud is compensated for his services as a consultant to the company. Stereotaxis Showcases Advancements for Remote Magnetic Ablations At the Boston Atrial Fibrillation Symposium, Stereotaxis, Inc. showcased three advances in remote magnetic ablation that it believes will enhance the efficiency, performance and versatility of its Niobe® Magnetic Navigation System. Stereotaxis exhibited its new software platform, Navigant 3.0, with the QuikCAS™ Cardiodrive® System for enhanced remote catheter control and improved EP lab workflow, and its partnered magnetic irrigated catheter, which is now available in Europe. "Together these three products represent a significant advancement in remote cardiovascular procedures," said Michael P. Kaminski, Stereotaxis President and CEO. • The QuikCAS Cardiodrive System remotely advances and retracts the catheter in the patient's heart while the Niobe magnets precisely steer the catheter's distal tip. The QuikCAS advancements provide the clinician with greater responsiveness for enhanced performance, a more ergonomic design and faster set-up for improved workflow. • Stereotaxis' partnered magnetic irrigated catheter, now available in Europe, is widely recognized as the gold standard for complex ablations such as ventricular tachycardia and complex left atrial arrhythmias. European clinicians have treated more than 600 patients with the magnetic irrigated catheter, with extremely positive results. Stereotaxis prepared a monograph of these results and highlighted the data at the Symposium. • Navigant 3.0 is Stereotaxis' new software platform for its Niobe Magnetic Navigation System. It provides users with many enhanced features and new capabilities that simplify and accelerate its use, including automated registration of the 3-D mapping system and calibration of the Cardiodrive System; faster and more accurate automation with re-targeting to compensate for patient movement; and broader integration with other EP lab systems. Particularly when used in combination with Odyssey™, Stereotaxis believes that Navigant 3.0 will significantly advance EP lab productivity and procedural workflow efficiency. In addition, clinicians could test drive the full Odyssey information management solution, including the new Odyssey Workstation 3.0 software and the Odyssey Cinema™ data management system for remote viewing and recording of live interventional cases. From an Odyssey Workstation, clinicians could control a catheter in a beating heart phantom located 1,200 miles away in the company's St. Louis headquarters. Alongside the Odyssey Workstation, clinicians could experience Odyssey Cinema for remote viewing, recording, playback and annotation of synchronized lab information showing the full context of the procedure. Odyssey Cinema could then broadcast their case through an Odyssey Connect network link to another hospital on the global Odyssey network, or during this conference to a partner's booth across the exhibit hall, allowing clinicians to experience the advantages of the Odyssey network for clinical collaboration, remote consultation, and training. "Some 18,000 procedures performed with the Niobe Magnetic Navigation System have established its reputation for clinical safety, utility, and efficacy," said Mr. Kaminski. For more information, please visit: www.afsymposium.com