Neurosurgeons have long sought imaging technology that could be applied not only before and after surgery, but during procedures to better find and extract tumors. Since the early 1990s, manufacturers have addressed this need with solutions ranging from image-guided workstations to dedicated surgical MRI devices and open MRI systems.
Now a new company, Odin Medical Technologies, has developed what it believes is the next step in the use of MR technology. PoleStar N-10, a compact, semi-portable, open system designed for brain surgery, can be used in a normal operating room.
PoleStar’s low-field magnet and small size give surgeons the option of performing brain surgeries on their home turf, according to executive vice president Christopher von Jako.
"We bring MR to the operating room, rather than the operating room to MR," von Jako said. "Our technology is flexible -- the surgeon is in his own environment, the anesthesiologist has full access to the patient, and both can use some standard neurosurgical equipment, such as microscopes and drills, rather than the special tools required to perform surgery in a specially designed MRI suite."
Newton, MA-based Odin Medical Technologies is the U.S. subsidiary of Odin Medical Technologies, which was founded in Yokneam, Israel in 1996 by Yuval Zuk and Ehud Katznelson, two former researchers with Israeli firm Elscint, which exited the medical imaging business in 1998. Another subsidiary, Odin Medical Technologies Europe, was born last February in Belgium. The company has 70 employees, including scientists, engineers, and medical specialists.
In November 2000, Odin Medical Technologies’ R&D efforts paid off when PoleStar received clearance from the Food and Drug Administration. The device was officially launched at this April’s American Association of Neurological Surgeons annual meeting in Toronto.
PoleStar allows surgeons to gather 3-D images at any time during brain surgery to better locate tumors, avoid healthy tissue, and image the margins of a tumor while the surgery is in progress. It also addresses the margin of error caused by brain shift -- the tendency of the brain’s surface and tumors to dislocate during a craniotomy, rendering preoperative MRI images inaccurate, according to Odin Medical.
Surgeons can also view postoperative images to make sure they’ve extracted the entire tumor before the patient leaves the operating room. PoleStar has been used in brain biopsies, craniotomies, and transsphenoidal surgeries.
PoleStar’s field-of-view is 16 x 11 cm, and its magnet has a field strength of 0.12 tesla. The device can be rolled under the operating table and raised into position with an infrared remote control. Once the unit has been positioned under the operating table, the patient’s head is held in place between two magnet poles by a special titanium three-pin holder developed by Odin Medical.
It takes one to seven minutes to image the patient, and the surgeon uses a wand placed on the patient’s head in the particular area of interest, which the system detects and displays on a monitor. Once preoperative images are taken, the surgeon lowers the device under the table and makes the initial incision. The process can be repeated until the surgeon has determined that all of the tumor has been removed and the surgery is complete.
The 1400-lb unit is stored in a cabinet in a standard operating room, rather than a special suite that would accommodate a typical eight- to ten-ton magnet. The cabinet blocks PoleStar’s magnetic field when it’s not in service, allowing the room to be used for other procedures, as well as intraoperative brain MRI surgeries.
In addition to space for the storage cabinet, the hospital needs an area at least 2 x 2 x 6 feet to accommodate PoleStar’s electronics, and the operating room needs to be protected either with copper shielding behind the walls or with shielding panels, both of which Odin can help install. If the shielding is a retrofit, the room can be out of commission for four to six weeks, according to von Jako.
Odin Medical has installed eight PoleStar systems. The device sells for approximately $800,000, although it can cost between $1 million and $1.5 million to install the complete system in a hospital’s OR if the facility also needs shielding and MR-compatible instruments such as clips and retractors.
The company’s primary marketing focus for PoleStar is hospital surgery departments, von Jako said, citing PoleStar’s compatibility with the operating room as one of its major draws.
"Right now we’re pushing toward the neurosurgeon market for PoleStar," he said. "Rather than sharing time on an MRI with a busy radiology department, neurosurgeons can schedule PoleStar brain surgeries at any time and use the device within a conventional operating room."
By Kate Madden Yee
AuntMinnie.com contributing editor
May 31, 2001
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