Remote Magnetic Navigation - Remote Magnetic Navigation

Remote Magnetic Navigation

This technique employed by companies such as Stereotaxis is unlike other robotic navigation techniques. The catheter is controlled by steering the distal tip with a magnetic field, making perforations virtually impossible. The engineering was developed at the University of Virginia, and the patent rights were later acquired by Stereotaxis, Inc. to market and develop a magnetic navigation system, according to its 2005 10-K filing with the SEC. The technology has been proven to reduce physician and patient exposure to radiation and procedure times, as well as enable more precise navigation of the vasculature with increased safety and efficacy. Additionally, remote magnetic navigation increases catheter stability while reducing the temperature required to successfully perform an ablation.

Traditional catheter labs in hospitals rely on the manual placement and steering of catheters by a physician. In interventional cardiology, catheters are used to map the cardiovascular system and to correct arrhythmias and atrial fibrillation, among other heart related problems, through a variety of methods including ablation. The patient is placed under a flouroscopic system, such as a C-arm, to give the EP real-time feedback on the positioning of the catheter. In manual procedures, the physician must wear a lead apron due to radiation exposure, whereas with RMN, the doctor can conduct the procedure in a shielded room or at another location via a network connection. Then ablation catheters are used to burn scars in heart tissue to correct irregular rhythms. Apart from ablation, cardiologists use guide wires and catheters to place stents and other devices in the anatomy.

Remote magnetic navigation operates by using two large magnets placed on either side of the patient, and alterations in the magnetic field produced by the magnets deflects the tips of catheters within the patient to the desired direction. The EP operates the catheter placement and direction in a shielded room with screens and a joystick. The catheter itself is advanced by the joystick, instead of the physician's hands. Stereotaxis offers software which enables automated mapping and other advantages through its Navigant suite. Due to the lack of irrigated catheters, completing ablation procedures with magnetic navigation has been difficult, especially in the left atrium. Magnetic irrigated catheters for Stereotaxis's Niobe MNS have been recently approved by the FDA on February 26, 2009, and the catheters have been commercially available in Europe since November, 2008. Dr. Andrea Natale remarked that the new magnetic irrigated catheters are "revolutionary" for the treatment of arrhythmias. It is unclear what kind of procedure Dr. Natale performed and if it was included within the FDA approved procedures. As of January 2009, 18,000 total clinical cases were performed by magnetic navigation according to Stereotaxis's website, with a complication rate of less than 0.1%, representing a minute fraction of complications occurring with manual and other robotic navigation systems. The Niobe has yet to report an instance of perforation during a procedure. The long term success, 6 month to 1 year, after ablation and cost effectiveness has yet to been approved by multicenter trials, however, single center studies have proven the Niobe superior in both categories when compared to manual techniques.

Installing an MNS may require that the catheter lab be equipped with steel plates and specialized equipment to prevent the magnetic fields from interfering with other equipment. Such installations can be costly and time consuming. According to the company, over 130 units have been installed worldwide, including the Cleveland Clinic, UCSF, the University of Michigan, Beth Israel, Kansas University Medical, Swedish Heart Hospital, Columbia Presbyterian, NYU and several hospitals in Europe, with close to 60 systems in the company's backlog.