Mobile and shared servicesprovider American Shared Hospital Services is styling itself asinterventional MRI's white knight. The San Francisco company isdeveloping a plan to offer interventional MRI scanners on a fee-for-servicebasis to luminary sites
Mobile and shared servicesprovider American Shared Hospital Services is styling itself asinterventional MRI's white knight. The San Francisco company isdeveloping a plan to offer interventional MRI scanners on a fee-for-servicebasis to luminary sites while building a database of clinicalstudies to support the widespread proliferation of the technology.
American Shared will unveil its plan at next week's RSNA show,although the company is quick to point out that interventionalMRI is a work-in-progress concept. No magnet has FDA clearanceto be marketed as an interventional unit, although scanners likeSiemens' Magnetom Open and Toshiba's Access have approval forgeneral imaging.
Getting FDA clearance for interventional applications is whereAmerican Shared comes in. The company intends to purchase interventionalMRI scanners from vendors once they get regulatory approval forgeneral imaging, then rent them to luminary sites on a fee-for-servicebasis. These 10 to 15 luminary sites will be the foundation ofan academic consortium that will gather clinical data to supportan FDA application for interventional MRI that American Sharedwill sponsor, according to Dr. Ernest Bates, chairman and CEO.
American Shared is working with clinicians at the Universityof California at Los Angeles in developing the consortium, Batessaid. The company is not sure whether it will be able to submita 510(k) application or must pursue the more rigorous pre-marketapproval (PMA) route.
American Shared will work with each luminary site in selectingthe appropriate magnet for its needs. Each facility will be ableto choose which vendor's magnet it wishes to rent, Bates said.Fee-for-service arrangements can carry considerable risk for vendorsif throughput does not meet certain levels, so American Sharedwill conduct due diligence to ensure that there is sufficientdemand for an interventional MRI scanner before contracting witha hospital. The plan is similar to American Shared's fee-for-serviceprogram for the Gamma Knife radiation therapy system.
American Shared also plans to act as a systems integrator byassembling components necessary for interventional MRI suites,such as workstations, software and surgical tools. The companyis working with Radionics, a medical instrumentation firm in Burlington,MA, that is developing a workstation for image-guided therapy.
The Radionics workstation is being integrated with Siemens'Magnetom Open scanner to provide frameless stereotactic correlationbetween image data and the position of instruments and tools usedduring surgery, according to Radionics CEO Eric R. Cosman. Otherimage-guided surgery workstations have been developed by ISG Technologiesand Picker International (SCAN 5/4/94 and 11/9/94).
The Radionics product will feature two different options tolocalize surgical tools to the workstation data, Cosman said.One method, the operating arm system (OAS), uses an articulatedmechanical arm. The other, the optical tracking system (OTS),uses an infrared tracking device.
The workstation can run on several different computer platforms,including DEC and Hewlett-Packard workstations. The Radionicsproduct is being used at the Center for Interventional MRI atUCLA Medical Center, which is installing a Magnetom Open scanner,Cosman said.