ST. LOUIS, Mo., December 22, 1998 -- A revolutionary system that uses superconducting magnets and advanced computer imaging technology to automatically navigate a catheter through the brain was tested successfully on the first patient last Thursday at Barnes-Jewish Hospital in St. Louis.
The system, approved for use under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption, is being evaluated as a potentially safer, less invasive, and more effective way to biopsy brain tumors. Future applications under development include diagnosing and treating cardiovascular conditions, such as coronary artery disease and cardiac arrhythmias, and treating neurovascular conditions such as aneurysms. The system was developed by Stereotaxis, Inc., a St. Louis-based company in the field of image-guided interventional medicine.
"Our new system fulfills a growing need for more efficient, cost-effective surgical techniques," said Bevil J. Hogg, president and chief executive officer of Stereotaxis. "While our initial focus has been on neurosurgical applications, we believe this system has the potential to be used in many cardiovascular and neurovascular procedures, as well." The first patient to undergo the procedure, a 31-year-old man, was diagnosed with a tumor in the frontal lobe of the brain. In all, five patients will participate in the first clinical trial of the Magnetic Surgery System at Barnes-Jewish Hospital.
The Magnetic Surgery System may prove to be a significant improvement over current stereotactic surgery. Presently, surgeons visualize the location of a brain tumor through MRI imaging technology, but must manually guide surgical instruments on a straight-line path to the target location, possibly passing through and damaging vital brain tissue.
"This new system is a fundamentally new approach to guiding surgical instruments during brain surgery," explained Dr. Ralph G. Dacey, professor and chairman of the Department of Neurological Surgery at Washington University School of Medicine in St. Louis and principal investigator of the trial. "Not only does this system allow us to follow a curved path through the brain, but for the first time a computer is able to steer a catheter using externally applied magnetic fields acting on the catheter tip, giving us greater navigational control."
Michael Lawson, program manager for intracerebral applications at Stereotaxis, explained that a thin, flexible guidewire which is tipped with a magnetic seed slightly larger than a grain of rice fits into a catheter. After inserting the guidewire and catheter into a small hole in the skull, the surgeon the uses the computer's mouse to chart a path for the catheter on a preoperative MRI image, avoiding important areas of the brain. The computer changes the magnetic field of the superconducting magnets that surround the patient's head, guiding the catheter along the predetermined curvilinear path through the brain.
The computer recalculates the position and the trajectory of the catheter every millimeter it travels. The entire navigation process takes less than 5 minutes. Once the catheter reaches the lesion, the guidewire is withdrawn, leaving the catheter in place. A highly flexible biopsy tool is inserted, the biopsy is taken and the catheter is removed.
"Our Magnetic Surgery System represents the first true interventional workstation, integrating magnets, computers and medical imaging. This combination allows for the direct distal-tip control of catheters which we believe will improve a clinician's ability to access remote areas of the body, improving diagnostic accuracy and treatment outcomes," said Hogg. "This clinical trial is an important step in demonstrating the effectiveness of this new model of interventional medicine."
Following the first clinical trial of the magnetic surgery system, Stereotaxis will submit the results to the FDA. The company will then seek the agency's approval to conduct a second clinical trial involving frontal lobe biopsies in a larger group of patients. After the second clinical trial, the company will seek FDA approval to commercialize the system.
Stereotaxis (http://www.stereotaxis.com) was founded in 1990 to further develop the pioneering work of several researchers at the University of Virginia, the University of Iowa, and the University of Washington in magnetic instrument guidance. The company is funded by a number of venture capital firms including Alafi Capital Company, CID Equity Partners, Graystone Venture Partners and Sanderling Ventures. Local St. Louis investors include Advantage Capital Partners, A.G. Edwards, BJC Health System, Community Investment Partners, Emerson Electric, Gateway Venture Partners, and Oakwood Investors.
Contact:
Tim Carley / 314-982-0263
Ellen Rostand / 314-982-9133
Press briefing scheduled for 11 a.m., Tuesday, December 22, in the Magnetic Surgery Suite, Barnes-Jewish Hospital.
Editor's Note: Press kit with fact sheet and camera-ready photographs are
available upon request.
Electronic images are available as well