Radically New Type Of Surgery Tested On First Patient

December 22, 1998

Press briefing at 11 a.m. Tuesday, Dec. 22, in the Magnetic Surgery Center, Barnes-Jewish Hospital. Call Linda Sage or Nicole Vines at 286-0100 for information.

St. Louis, Dec. 21, 1998 -- Neurosurgeons have performed the first human magnetic surgery.

"This is a fundamentally new way of manipulating surgical tools within the brain that promises to be minimally invasive," says Ralph Dacey, M.D. "And it should be a safer way of doing brain surgery because it allows us to use a curved pathway to reach a target. Therefore we can go around sensitive structures, such as those that control speech or vision, instead of going through them."

Dacey is the Edith R. and Henry G. Schwartz Professor and head of neurological surgery at Washington University School of Medicine in St. Louis. He is testing the new technology, called the Magnetic Surgery System (MSS), by biopsying five patients with tumors in the upper front part of the brain. A biopsy removes a small piece of tissue, enabling physicians to identify a tumor, determine whether it is malignant and plan appropriate treatment.

The first patient, a 31-year-old man, underwent the magnetic surgery Dec. 17 at Barnes-Jewish Hospital in St. Louis. Dacey used computer-controlled superconducting magnets to remotely direct a small flexible biopsy instrument into the patient's brain.

This advanced medical technology has been under development for more than a decade at universities and national laboratories throughout the United States. A St. Louis-based company called Stereotaxis Inc. is spearheading its commercial development.

"We expect the system to have a wide range of applications because it puts three components - visualization, localization and navigation - together for the first time, creating an interventional workstation," says Bevil Hogg, the company's CEO. "Future possibilities may include implanting electrodes into the brains of patients with movement disorders, repair of aneurysms and other blood vessel abnormalities, delivering therapeutic drugs or chemotherapy agents to parts of the brain, cardiac electrophysiology and removal of arterial plaque."

Surgeons currently use images of the brain to see a tumor, and they can localize instruments that have sensors. But until now, there has been no way to automatically navigate tools through the brain along an optimal path. To obtain a biopsy, for example, neurosurgeons manually push a rigid needle toward a tumor, passing through whatever lies en route. The MSS, which looks like a magnetic resonance imager, directs a catheter to a predetermined part of the brain along a pathway planned by the surgeon.

Matthew A. Howard III, M.D., associate professor of neurosurgery at the University of Iowa, and M. Sean Grady, M.D., professor of neurosurgery at the University of Washington, accompanied Dacey during the surgery. Howard and Grady are co-inventors of the original magnetic surgery system, along with Rogers Ritter, Ph.D., professor of physics at the University of Virginia. Howard conceived the idea in 1984, when he was a medical student at the University of Virginia.

Last week's surgery began when Dacey drilled a finger-sized hole in the patient's skull. He placed a plastic bolt in the hole to provide a subsequent entryway for surgical instruments. He also attached six small metal markers to the outside of the skull to enable the computer to localize the catheter (see attached backgrounder).

Dacey then viewed magnetic resonance images (MRIs) of the patient's brain on the screen of a computer console. The 3-D views and virtual slices through the brain allowed him to plan the best route to the tumor.

The surgeons next placed the patient's head in the MSS, positioning it between the superconducting magnets with a titanium frame. Opening the plastic bolt in the skull, they introduced a tiny magnet into the brain. The magnet was attached to a guidewire, which was covered by a plastic catheter. "The catheter is much narrower than a drinking straw but a bit fatter than spaghetti," says Andrew F. Hall, D.Sc., the company's cardiovascular program manager.

Sitting at the computer console, Dacey guided the small magnet to the tumor. As the magnet moved along the preplanned path, the computer advanced the guidewire and catheter one millimeter at a time, always checking the trajectory.

After the magnet reached the tumor - about a 5-minute trip - Dacey gently pulled it and the guidewire out of the brain, leaving the catheter in place to act as a tunnel. He then inserted a specially designed biopsy tool along the catheter. Because the tool was flexible, it followed the preplanned path. A few minutes later, Dacey had snipped out a tissue sample for the pathology lab. After taking additional samples from other parts of the tumor, he removed the catheter and cranial bolt and closed the small hole in the skull.

"This is the first time magnetic surgery has been done anywhere in the world," Dacey says. "It eventually should allow us to be much more innovative in delivering electrodes or drugs for direct therapy of a variety of brain diseases."

The following visuals are available:
The Magnetic Surgery System
Head shot of Dr. Dacey
Graphic explaining how the MSS works
Dr. Dacey at the computer console of the MSS
Computer image showing a path to the patient's tumor
Dr. Dacey in front of the MSS
The three inventors of the MSS

Magnetic Surgery Backgrounder

How is the small magnet guided through the brain?
The MSS generates a magnetic field whose contours are determined by the strength of the current flowing to each of six superconducting magnets. Increasing or decreasing the current to one magnet alters the contours of the field, which alters the direction in which the small magnet moves.

Does the small magnet pull the guidewire and catheter?
No. A computer-controlled device, the guidewire positioning system, provides the mechanical force to advance the guidewire. So the positioning system is like the system's motor, whereas the magnet is like its steering wheel. The surgeon steers by remote control from the computer console.

How does the surgeon know where the small magnet is in the brain?
The MSS contains a fluoroscope, which takes X-ray images in two planes of the patient's head every second or two. Because the six metal markers show up on these images as well as on the MRIs, the two types of images can be superimposed. Therefore the computer can mark the position of the magnet - which the fluoroscope detects - on the MRI images in the computer console. These images also display the predetermined path to the tumor.

Who invented the MSS?
In 1984, Matthew Howard thought of using a magnetic field to guide instruments into the brain. He and a University of Virginia neurosurgery resident, M. Sean Grady, now a professor of neurosurgery at the University of Washington in Seattle, approached Rogers Ritter, Ph.D., a professor of physics at the University of Virginia. For the next few years, they and George T. Gillies, Ph.D., a research professor of mechanical engineering and biomedical engineering at the University of Virginia, conducted feasibility studies. Then in 1990, the four researchers and Sanderling, a venture capital company in Menlo Park, Calif., formed Stereotaxis Inc. The company moved to St. Louis in 1995 because Washington University School of Medicine in St. Louis and Barnes-Jewish Hospital are leaders in neurosurgery.

What were the major challenges?
Developing the algorithms and technology to manage the magnetic field was a major challenge because field strength must change rapidly in response to computer commands. Designing the X-ray system also was a challenge because magnetic fields destroy standard fluoroscopes. Stereotaxis also had to develop flexible surgical tools and Jello-based "brain tissue" for practicing the surgical maneuvers.

Who is financing the research?
The major investors are: Advantage Capital Partners (St. Louis), Alafi Capital (Emeryville, Calif.), BJC Health System Inc. (St. Louis), CID Equity Partners (Indianapolis, Ind.), Community Investment Partners II, LP (St. Louis), A.G. Edwards (St. Louis), an investment subsidiary of Emerson Electric (St. Louis), Gateway Venture Partners (St. Louis), Graystone Venture Partners (Northfield, Ill.), Oakwood Investors (St. Louis), Sanderling Venture Partners II, LP (Menlo Park, Calif.).

What happens at the end of this study?
Stereotaxis will submit the data from the five patients to the U.S. Food and Drug Administration, requesting permission to proceed to the second phase of human trials. Phase II will involve about 30 patients at two medical schools, one of which will be Washington University School of Medicine in St. Louis. After Phase II, the company will seek approval to commercialize the MSS.

What are possible future applications?
The MSS could find applications in urology (for reaching prostate tumors), gastroenterology, cardiology and other fields of interventional medicine. For example, it could be used to reach parts of the heart that have an abnormal electrical rhythm or to clean out arteries blocked with plaque. In the brain, it might be able to guide instruments through a blood vessel to repair an aneurysm or venous malformation. The MSS also might be able to disseminate drugs directly into tumors through catheters that act like a soaker hose.
-end-


Washington University School of Medicine

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