Medical Device Daily Staff Writer

St. Jude Medical (St. Paul, Minnesota), reported the launch of its MediGuide Technology, a three-dimensional (3-D) navigation system intended for the evaluation of vascular and cardiac anatomy on a recorded fluoroscopic image instead of live fluoroscopy (a series of X-ray images).

The use of recorded images allows physicians to reduce the duration of radiation exposure during cardiovascular procedures, revolutionizing medical imaging procedures in the electrophysiology (EP) lab.

"The launch of MediGuide Technology is significant as it allows clinicians to perform cardiac procedures with less fluoroscopy and the corresponding exposure to harmful radiation," said Dhanunjaya Lakkireddy, MD, cardiologist at the University of Kansas Hospital (Kansas City), the first medical facility in the U.S. to use the MediGuide Technology system. "This revolutionary system reduces the need for live fluoroscopy, while providing unprecedented views inside the heart, improving complex cardiac resynchronization therapy and cardiac ablation image-guided procedures for physicians, patients and medical staff around the world."

According to the company, the MediGuide system first received 510(k) clearance in 2009 and since that date, MediGuide enabled tools were also 510(k) cleared to be used with the system. The MediGuide system is also approved in Europe.

The device is described as being similar to a GPS tracking system.

"Similar to a GPS tracking system, MediGuide allows physicians to see the precise location and orientation of the MediGuide Enabled tools within the cardiac anatomy," a company spokesperson wrote in an e-mailed response sent to Medical Device Daily. "The system automatically adjusts for cardiac motion, respiratory and patient movement. Catheter location is accurately tracked within 1 mm and 1 degree on live and pre-recorded fluoroscopy images. Anatomical markers on the pre-recorded image provide additional perspective and improved workflow during catheter navigation."

Using magnetic tracking to locate miniature sensors embedded in devices, such as the MediGuide Enabled Livewire Diagnostic Catheter and the CPS Excel MediGuide Enable Guidewire, this technology applies 3-D visualization to previously recorded fluoroscopic images in real-time. Automatic adjustments are made to the recorded images to maintain an accurate real-time clinical representation compensating for cardiac motion, respiratory changes and patient movements in order to minimize workflow delays.

"MediGuide Technology is the only real-time cardiac navigation and visualization platform that allows physicians to reduce fluoroscopy during cardiac procedures," said Frank Callaghan, president of the St. Jude Medical cardiovascular and ablation technologies division. "St. Jude Medical continues to be committed to developing technologies that minimize radiation exposure in the EP lab, improve procedural repeatability and increase clinical and economic efficiency."

The MediGuide technology was bought by St. Jude Medical when the company acquired MediGuide 2008 (Medical Device Daily, Dec. 23, 2008).

St. Jude acquired the company because MediGuide had developed a navigation system, the Medical Positioning System (gMPS) that uses technology for real-time tracking of sub-millimeter sized sensors. These sensors can be mounted on needles, guidewires, catheters, and other devices used for minimally-invasive intra-body navigation, St. Jude said. The 3-D position and orientation of the sensors can be calculated in real time and projected graphically on a fluoroscope, CT, MRI, ultrasound, or 3-D reconstructed image of the anatomy.

The recently launched MediGuide system and enabled tools were created and continue to be developed in-house.

Recently, the company has been making med-tech headlines regarding its work in treating migraines.

Last week, St. Jude reported publication of results from the first large-scale study of peripheral nerve stimulation (PNS) of the occipital nerves in patients suffering from chronic migraine (MDD, Oct. 5, 2012). The study results show a significant reduction in pain, headache days and migraine-related disability.

Last month, the company said it received CE mark approval of its Eon family of neurostimulators for patients with intractable chronic migraine. Unveiled at the European Headache and Migraine Trust International Congress in London, this approval includes the Eon Mini neurostimulator, which it calls the world's smallest rechargeable neurostimulator with the longest-lasting battery in its class, and the Eon and EonC neurostimulators (MDD, Sept. 24, 2012). Preceding the Eon family approvals, the company received the CE mark for its Genesis neurostimulation system, the industry's first regulatory approval for an implanted neurostimulation device to treat patients with intractable chronic migraine.

Omar Ford, 404-262-5546;

omar.ford@ahcmedia.com

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