Medtronic Receives 510(k) Clearance for PoleStar Neuro-oncology Surgical MRI System

Medtronic has received U.S. Food and Drug Administration 510(K) clearance and has launched the PoleStar N30 Surgical MRI system, the latest in neuro-oncology surgical solutions, in the United States, according to a Medtronic news release.

The PoleStar Surgical MRI provides surgeons real-time imaging in the operating room and targeting and navigational accuracy despite the anatomy movement that may occur during a surgical procedure, according to the release. The intra-operative imaging information allows neurosurgeons to achieve maximum tumor resection while avoiding critical areas of the brain and may reduce the need for revision surgeries and reduce a patient's length of stay at the hospital.

More than 50 PoleStar systems have been installed in ORs worldwide since 2001. 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, according to the release.

Read the Medtronic release on the PoleStar N30 Surgical MRI system.