FDA okays Otsuka MRI system for marketing

Otsuka Electronics has gained Food and Drug Administration clearanceto sell its OE 1.5 SI MRI system in the U.S. (SCAN 12/25/91 and2/11/92). The Fort Collins, CO, company was notified about theFDA action July 20. Its 510(k) application was submitted Feb.5.

The first 1.5-tesla unit will be installed at Barnes West Hospitalin St. Louis, said Dale Grant, Otsuka marketing vice president.The service is a collaboration between the hospital and MallinckrodtInstitute, also in St. Louis. Other shipments will begin in September,Grant said.

The price and design of the OE 1.5 SI system attracted attentionwhen the Japanese-owned company introduced the product at lastyear's RSNA conference. The $1.2 million system is the lowestpriced high-field product sold in the U.S. market. It is alsothe only superconducting system in the current generation of MRIsystems to depart from whole-body scanning. The design featuresremovable gradient and radio-frequency coils dedicated to specificapplications.

Engineering problems with its innovative flat gradient coilsfor spinal and shoulder applications recently forced changes tothe system's configuration. The company set aside the flat gradientapproach in favor of a cylindrical large-volume gradient. As withthe head and extremity coil, the large-volume gradient is removable.

The company backed away from the flat gradient design whenprototypes powerful enough to produce adequate fields of viewproved to be too large for the magnet, Grant said.

Otsuka has not abandoned the approach, however. "We aregoing to continue to work toward an efficient flat gradient systembecause it seems to have a lot of flexibility and potential,"Grant said.

On the plus side, the announcement that Otsuka's first systemwill be installed at a Mallinckrodt-affiliated facility indicatesluminary sites are willing to conduct research with the equipment.

Gaining access to top-flight centers has been no small taskfor Otsuka. In January, the prestigious Barrow Research Institutein Phoenix reneged on a commitment to experiment with the OE system.Officially, Barrow backed away because the facility was overloadedwith projects. Another factor in Barrow's decision, however, mayhave been a threat by GE to withdraw its research support fromthe institute, according to industry sources.

This identical scenario was apparently played out at two otherhigh-profile facilities.

"GE scared a couple away," Grant acknowledged.