Doctors Use Computer to Navigate Instrument Within the Blood Vessels of The Human Brain

Clinical Trial Could Be First Step Toward Helping Thousands of People With

Brain Aneurysms



Apr 16, 2001, 01:00 ET from Stereotaxis, Inc.

    ST. LOUIS, April 16 /PRNewswire/ -- Washington University physicians at
 Barnes-Jewish Hospital in St. Louis completed the first use of a Magnetic
 Navigation System designed to use computer-controlled magnetic fields to steer
 an instrument within the blood vessels of the brain to reach an aneurysm, an
 abnormal blood-filled dilation of a blood vessel.  Two procedures were
 successfully completed last week on a 55-year-old man and a 64-year-old woman
 by Dr. Christopher J. Moran.  Although clinicians regularly navigate
 instruments (typically catheters or guidewires) manually to the brain via the
 femoral artery for the repair of aneurysms, this is the first time the
 instrument has been steered via computer-controlled magnetic fields.
     The system, approved for use in clinical trials by the U.S. Food and Drug
 Administration (FDA) under an Investigational Device Exemption (IDE), is being
 tested as a new way to navigate devices within the brain and the heart.
     The system was developed by Stereotaxis, Inc., a St. Louis-based company
 in the field of interventional robotics.  The technology integrates a magnetic
 field actuator with image guidance techniques and computer control to create
 an interventional workstation, with the potential to provide remote digital
 navigation of catheter-based therapeutic or diagnostic devices along complex
 trajectories within the body.
     "The field of interventional medicine is being revolutionized through
 computer integration in the cath lab, and Stereotaxis is at the forefront of
 the technology," said Bevil J. Hogg, president and chief executive officer of
 Stereotaxis.  "The medical community has a growing need for more efficient,
 cost-effective and, above all, less invasive interventional procedures.  Our
 new system has the potential to fulfill that need through the use of digitally
 controlled catheters.  In providing programmatic control of catheters and
 other interventional devices, Stereotaxis expects to play a key role in the
 rapidly increasing computerization of the catheterization laboratory."
     Dr. Moran, an associate professor of radiology at Washington University
 School of Medicine, is the principal investigator who, along with several
 other interventional neuroradiologists, is leading the clinical trial at
 Barnes-Jewish Hospital.
     "Reaching the site of a brain aneurysm has always been a difficult
 procedure, but this new technology has the potential to improve the way we can
 gain access to sites in the brain during a procedure within the vascular
 system," said Dr. Moran.  "This new system addresses the challenges we face
 with this type of procedure.  For the first time, we used a computer to help
 us steer the instrument through the blood vessels to the brain."
     According to Dr. Moran, clinicians currently must manually navigate
 devices from the femoral artery to the brain.  With the Magnetic Navigation
 System, under the direction of the physician, the computer is designed to
 steer the instrument, directly at the distal tip, to various vessels supplying
 the brain in order to access the site of the aneurysm.
     "Globally, there are about 80,000 aneurysm patients discovered each year.
 An untreated, ruptured aneurysm may result in death," Dr. Moran said.
 "Therefore, it's critical that we have a means of accurately and quickly
 locating and treating the source of the bleeding."
     The study also encompasses using the catheter to navigate to sites for the
 subsequent treatment of stroke, arterial venous malformations, and other
 embolization procedures.
     Thirty patients will participate in the clinical trial in St. Louis.
 Testing is expected to be complete in 2001.
     This is the third clinical trial for the Magnetic Navigation System.  The
 second trial began in January at Washington University School of Medicine
 using a magnetically controlled catheter to navigate within the heart to
 discover the source of cardiac arrhythmias.  The cardiac trial is nearly
 halfway complete.  The first trial in 1998 involved using a magnetically-
 guided biopsy device in neurosurgery.
 
     Stereotaxis (www.stereotaxis.com) was founded in 1990 to further develop
 the pioneering work in magnetic instrument guidance by several researchers at
 the University of Virginia, University of Iowa, and the University of
 Washington.  The company is funded by a number of prominent venture capital
 firms.
 
     Washington University School of Medicine in St. Louis is considered one of
 the top five medical schools in the country, known for providing excellence in
 medical research, teaching, and patient care.  The school receives more than
 $300 million a year in grants and contracts to support its research efforts,
 which ultimately are geared toward finding treatments and cures for
 devastating diseases.  The school also ranks first nationwide in student
 selectivity, meaning its students are of the highest caliber.  The medical
 school faculty are the physicians and surgeons who provide cutting-edge
 medical care to the patients of Barnes-Jewish and St. Louis Children's
 Hospitals.
 
 

SOURCE Stereotaxis, Inc.
    ST. LOUIS, April 16 /PRNewswire/ -- Washington University physicians at
 Barnes-Jewish Hospital in St. Louis completed the first use of a Magnetic
 Navigation System designed to use computer-controlled magnetic fields to steer
 an instrument within the blood vessels of the brain to reach an aneurysm, an
 abnormal blood-filled dilation of a blood vessel.  Two procedures were
 successfully completed last week on a 55-year-old man and a 64-year-old woman
 by Dr. Christopher J. Moran.  Although clinicians regularly navigate
 instruments (typically catheters or guidewires) manually to the brain via the
 femoral artery for the repair of aneurysms, this is the first time the
 instrument has been steered via computer-controlled magnetic fields.
     The system, approved for use in clinical trials by the U.S. Food and Drug
 Administration (FDA) under an Investigational Device Exemption (IDE), is being
 tested as a new way to navigate devices within the brain and the heart.
     The system was developed by Stereotaxis, Inc., a St. Louis-based company
 in the field of interventional robotics.  The technology integrates a magnetic
 field actuator with image guidance techniques and computer control to create
 an interventional workstation, with the potential to provide remote digital
 navigation of catheter-based therapeutic or diagnostic devices along complex
 trajectories within the body.
     "The field of interventional medicine is being revolutionized through
 computer integration in the cath lab, and Stereotaxis is at the forefront of
 the technology," said Bevil J. Hogg, president and chief executive officer of
 Stereotaxis.  "The medical community has a growing need for more efficient,
 cost-effective and, above all, less invasive interventional procedures.  Our
 new system has the potential to fulfill that need through the use of digitally
 controlled catheters.  In providing programmatic control of catheters and
 other interventional devices, Stereotaxis expects to play a key role in the
 rapidly increasing computerization of the catheterization laboratory."
     Dr. Moran, an associate professor of radiology at Washington University
 School of Medicine, is the principal investigator who, along with several
 other interventional neuroradiologists, is leading the clinical trial at
 Barnes-Jewish Hospital.
     "Reaching the site of a brain aneurysm has always been a difficult
 procedure, but this new technology has the potential to improve the way we can
 gain access to sites in the brain during a procedure within the vascular
 system," said Dr. Moran.  "This new system addresses the challenges we face
 with this type of procedure.  For the first time, we used a computer to help
 us steer the instrument through the blood vessels to the brain."
     According to Dr. Moran, clinicians currently must manually navigate
 devices from the femoral artery to the brain.  With the Magnetic Navigation
 System, under the direction of the physician, the computer is designed to
 steer the instrument, directly at the distal tip, to various vessels supplying
 the brain in order to access the site of the aneurysm.
     "Globally, there are about 80,000 aneurysm patients discovered each year.
 An untreated, ruptured aneurysm may result in death," Dr. Moran said.
 "Therefore, it's critical that we have a means of accurately and quickly
 locating and treating the source of the bleeding."
     The study also encompasses using the catheter to navigate to sites for the
 subsequent treatment of stroke, arterial venous malformations, and other
 embolization procedures.
     Thirty patients will participate in the clinical trial in St. Louis.
 Testing is expected to be complete in 2001.
     This is the third clinical trial for the Magnetic Navigation System.  The
 second trial began in January at Washington University School of Medicine
 using a magnetically controlled catheter to navigate within the heart to
 discover the source of cardiac arrhythmias.  The cardiac trial is nearly
 halfway complete.  The first trial in 1998 involved using a magnetically-
 guided biopsy device in neurosurgery.
 
     Stereotaxis (www.stereotaxis.com) was founded in 1990 to further develop
 the pioneering work in magnetic instrument guidance by several researchers at
 the University of Virginia, University of Iowa, and the University of
 Washington.  The company is funded by a number of prominent venture capital
 firms.
 
     Washington University School of Medicine in St. Louis is considered one of
 the top five medical schools in the country, known for providing excellence in
 medical research, teaching, and patient care.  The school receives more than
 $300 million a year in grants and contracts to support its research efforts,
 which ultimately are geared toward finding treatments and cures for
 devastating diseases.  The school also ranks first nationwide in student
 selectivity, meaning its students are of the highest caliber.  The medical
 school faculty are the physicians and surgeons who provide cutting-edge
 medical care to the patients of Barnes-Jewish and St. Louis Children's
 Hospitals.
 
 SOURCE  Stereotaxis, Inc.