First Patient Procedure Using the ClearPoint System
Memphis, Tennessee, August 10, 2010 – SurgiVision, Inc. announced today that the first patient procedure using its ClearPoint™ Neuro Intervention System (ClearPoint) has been successfully performed by physicians and scientists at the University of California, San Francisco (UCSF) Medical Center. The UCSF team was led by Dr. Philip Starr, Professor of Neurological Surgery and Co-Director of the Functional Neurosurgery Program; Dr. Paul Larson, Associate Professor of Neurological Surgery; and Dr. Alastair Martin, Adjunct Professor, Department of Radiology and Biomedical Imaging.
SurgiVision’s ClearPoint system is an integrated system of reusable components, disposable components and intuitive, menu-driven software. Using the ClearPoint system, a physician sees and selects a neurological target, aims SurgiVision’s targeting device and watches via magnetic resonance imaging (MRI) as the surgical instrument is advanced to the target. In June 2010, SurgiVision received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the ClearPoint system in the United States.
The ClearPoint system provides guidance for the placement and operation of instruments or devices during the planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint system is intended to be used as an integral part of procedures, such as biopsies and catheter and electrode insertions, which have traditionally been performed using stereotactic methods, and it is designed to allow those procedures to be performed in a hospital’s existing MRI suite.
Kimble Jenkins, SurgiVision’s Chief Executive Officer, commented, “We are extremely pleased to announce the first patient procedure using our ClearPoint system by the team within UCSF’s Departments of Neurological Surgery and Radiology. This initial procedure is a major milestone for our company and for the field of MRI-guided interventions.”
“Performing minimally invasive procedures in the brain presents special challenges, including a need to reach small therapeutic targets often located deep within the brain. Utilizing the imaging power of MRI, we believe our ClearPoint system addresses these challenges and can become the platform-of-choice for performing the next generation of minimally invasive procedures in the brain,” concluded Mr. Jenkins.
Speaking on behalf of the surgical team that performed the ClearPoint system procedure, Dr. Philip Starr added, “High precision access to deep brain targets has, in the past, utilized methods that are time consuming and that can be difficult for some patients to tolerate. Among other benefits, an MRI-guided approach offers direct image guidance during the surgery and may provide the surgeon with the ability to immediately detect any complications. Interventional MRI-guided neurosurgery, conceived 15 years ago for the treatment of brain tumors, has tremendous potential for the delivery of devices to deep brain targets.”