GE prepares to buy image guided surgery firm

Acquisition would mark strategic shift

GE Medical Systems is about to launch a long-range plan that company strategists hope will change the practice of x-ray angiography and cardiac catheterization. Central to this plan is the acquisition, announced Feb. 13, of Visualization Technology, a small Lawrence, MA, company specializing in image guidance for surgical interventions. The goal, according to GE executives, is to use this company's technology and expertise to transform high-end x-ray fluoroscopy into a purely interventional technology.

Industry pundits have predicted for years that premium-performance x-ray fluoroscopy, now used as both a diagnostic and real-time interventional tool, must eventually focus entirely on therapeutics. Multislice CT and high-speed MR have been steadily closing the clinical utility gap with x-ray angiography for both peripheral and coronary diagnoses. Soon these two modalities will be viable alternatives to conventional vascular technologies.

"We see MR and CT being the diagnostic tools and angiography being used in intervention," said Ruben C. Berumen, general manager of GE's global surgery and vascular imaging business unit.

GE began planning for this transition when the company turned OEC Medical, a premier developer of mobile C-arms acquired in 1999, into the cornerstone of its global surgery and vascular imaging business unit. The aim then, as now, was to use digital imaging technology and advanced processing algorithms to perform minimally invasive therapy. The use of these technologies together promises to cut costs by reducing the time needed to do interventions. It should also reduce morbidity by minimizing trauma to the patient and reduce radiation dose to the patient as well as the medical staff.

"Interventionalists have to be worried about their own exposure," Berumen said. "These physicians have their hands in the x-ray field eight, 10, 12 hours a day. Anything that reduces dose without sacrificing the ability to visualize what they are doing is of interest to them."

The acquisition and integration of Visualization Technology will help GE bring this capability to the interventional community. The deal will not be final until due diligence is completed, but that won't take long. Berumen expects closure within the next six weeks.

What makes the privately held firm especially attractive to GE is its electromagnetic (EM) sensor technology. This tracks a surgical probe in virtual 3D space, providing information needed to update a 3D virtual model that guides interventionalists during procedures. Sensors built into competing image guidance systems require a line of sight from a transmitter mounted on the probe to optical sensors located strategically in the operating theater. EM technology does not.

"This approach allows us to attach EM sensors to the tips of surgical instruments that, after they enter the body, have no direct line of sight to outside tracking devices," said Dr. Maurice R. Ferre, president and CEO of Visualization Technology. "Optically based navigational systems do require this line of sight, and this limits their ability to relay positional data of the probe inside the body."

Visualization Technology was founded in 1993 on early research done at Brigham and Women's Hospital Surgical Planning Lab in Boston, where the concept of electromagnetic tracking was first developed. A major challenge facing engineers at the fledgling company was to overcome distortions in the electromagnetic field caused by metal surgical probes. This problem was solved by 1996. Today Visualization Technology's InstaTrak products help about 900 physicians worldwide perform minimally invasive cranial and ear, nose, and throat surgeries.

Aside from the innovative sensors, InstaTrak products are much like other image guidance systems, reformatting CT or MR data into 3D models that allow surgical planning and provide feedback during surgery. Two years ago, however, engineers at Visualization Technology and GE began collaborating on a product that could update the 3D model with real-time x-ray images. The alliance, sealed with an equity investment by GE, led to the development of FluoroTrak, which combines a C-arm system with InstaTrak hardware and software. One version is coupled with the OEC 9800; another is compatible with other C-arms.

InstaTrak and FluoroTrak create 3D models from MR and CT data obtained prior to the procedure. FluoroTrak has the advantage of updating these models and verifying the position of tissue and the surgical probe on the fly with real-time x-ray fluoroscopy.

Optimized to assist in orthopedic and spinal interventions, FluoroTrak is now operating at several sites. GE plans to slowly expand the group of users, building support for the use of real-time image guidance during orthopedic interventions.

"Physicians have to get their hands on the equipment so they can help us develop the technology, but we've also found that the decision to buy is made when the interventionalists are in scrubs," Berumen said. "They don't get wowed by fact and data sheets. They get wowed by seeing technology in use."

FluoroTrak 9800 is the first hybrid combining x-ray imaging and image guidance, but it will not be the last. The concept of integrating image guidance technology and imaging products will be extended to x-ray angio products and to flat-panel cardiac catheterization equipment.

"We see a real opportunity for taking flat panels and surgical navigation systems into cardiac and vascular suites," Berumen said.

The key to developing these applications will be incorporating EM microsensors into the disposable products that make cardiac and vascular procedures possible.

"We have already resolved a lot of the issues in regard to integrating navigation to a fluoro system," Ferre said. "The next step is to integrate sensors on the tips of catheters. This will open up a lot of applications and opportunities in the imaging world."

GE plans to win acceptance for these advanced systems by working with interventionalists to develop and refine procedures. The equipment will be developed on open platforms, which will work in conjunction with any intraoperative tools, instruments, or implants, regardless of manufacturer, Berumen said. This will speed the acceptance of image-guided intervention by allowing medical teams to pick the best surgical tools for the procedure.

"Right now different navigational systems are tied into the use of specific surgical probes or orthopedic devices or stents," he said. "Beginning with the FluoroTrak 9800, we made a conscious decision to be open to the use of all types of devices. We believe that having this open architecture will really be a game changer.