Medtronic receives FDA 510(K) clearance for PoleStar N30 Surgical MRI system

Medtronic (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) 510(K) clearance and U.S. launch of the PoleStar® N30 Surgical MRI system, the latest in neuro oncology surgical solutions.

“This is the next generation of intra-operative MRI providing flexibility, enhanced ergonomics and confidence in the achievement of surgical goals”

Providing real-time imaging in the operating room (OR), the PoleStar Surgical MRI provides surgeons with targeting and navigational accuracy despite the anatomy movement that may occur during a surgical procedure. With intra-operative imaging information, neurosurgeons gain more confidence to achieve maximum tumor resection, while avoiding critical areas of the brain. Use of the PoleStar system may also reduce the need for revision surgeries and the length of stay at the hospital for the patient.

"This is the next generation of intra-operative MRI providing flexibility, enhanced ergonomics and confidence in the achievement of surgical goals," said Jim Cloar, vice president and general manager of the Navigation division, part of the Surgical Technologies business at Medtronic. "With its unique compact design, the PoleStar Surgical MRI system enables neurosurgeons to benefit from intra-operative MR imaging without the compromises inherent in other systems, such as extensive renovation of the operating room or restrictions upon the surgeons' choice of instruments."

Dr. Moshe Hadani, Chairman of Neurosurgery, Sheba Medical Center in Israel was a frequent user of the previous model of the PoleStar Surgical MRI. "Recently we installed the PoleStar N30 System. We have found the new PoleStar to have great improvements in ergonomics. The scanner is smaller, easier to handle and it fits better into the OR environment. Using the PoleStar, I have great confidence in the extent of tumor resection prior to closing."

More than 50 PoleStar systems have been installed in ORs worldwide since 2001. The launch of the PoleStar N30 is the culmination of six years of research and development by Medtronic scientists and engineers working with surgeon customers from leading hospitals and clinics.

The PoleStar N30 system received the Chicago Athenaeum Museum of Architecture and Design 2009 Good Design Award - the world's oldest and most prestigious award for global design excellence.