GE prepares to commercialize high-energy ultrasound device

GE Healthcare strategists are hoping to launch an ultrasound-based therapy system at the RSNA meeting this November. The ExAblate 2000 is built into the patient table configured with GE's Signa 1.5T MR scanner. The scanner provides the images that operators use to guide a tightly focused ultrasound beam to its target and allows the ablative effects of the beam to be monitored with real-time MR thermometry. This technique detects temperature changes in tissue using temperature-dependent phase changes in proton resonance frequency.

In June, the FDA Obstetrics and Gynecology Devices Panel recommended conditional approval of the ExAblate 2000 for noninvasive treatment of uterine fibroids. Final approval could be in hand by the start of the RSNA meeting, according to Dave Weber, Ph.D., manager of global high-field MR business for GE. If so, the company plans to make the most of it.

"It is going to be big," Weber said. "We plan to put it at the center of our booth."

ExAblate 2000 is already CE-certified for the treatment of uterine fibroids in Europe. The technology might also be used in the treatment of benign breast fibroadenomas, as well as brain, liver, and bone tumors. The ultrasound beam emitted by ExAblate 2000 can destroy diseased tissue in seconds.

"It has remote mechanical guidance that you can use to focus ultrasound energy to a pinpoint within the patient," Weber said.

The sound waves carry more energy than those used in diagnostic ultrasound, and they are focused on a single point, rather than spread over a large area. Tissues just a few millimeters away experience only a limited temperature rise, which dissipates through normal body conduction and perfusion.

GE began studying the use of high-energy ultrasound for this purpose more than a decade ago. The company installed a prototype system in 1995. Two years later, Elbit Medical Imaging (EMI), an Israeli investment and holding company, began experimenting with the technology through its ultrasound company Diasonic-Vingmed Ultrasound, which GE acquired in April 1998 (SCAN 4/29/98). A year later, InSightec was founded as a joint venture between GE and EMI.

Shares in the company are currently split between EMI (54%) and GE (20%), with InSightec employees holding the remainder.

EMI's large, continuous investment in InSightec's R&D has been supported by profitable real estate investments (SCAN 7/23/03).

The company owns a growing string of Plaza Center shopping malls throughout Central and Eastern Europe. Its second subsidiary, Elscint, operates a chain of hotels in Western Europe and an entertainment center in Israel. Elscint sold its last diagnostic imaging interests two years ago.