Otsuka Plans Effort With Kontron to Launch MRI System in Europe

MRI supplier Otsuka Electronics of Fort Collins, CO, plans toenter the European market this year through a distribution agreementwith Kontron Instruments of France, according to John Ariatti,Otsuka sales & marketing director. An agreement in principlebetween the two companies was reached late last year. Finalizationof the pact is expected in the next 30 days.

Otsuka hopes to place its first MRI system in Europe by thethird quarter of this year, he said. A Latin American launch isalso targeted for 1994, with Asian sales planned for 1995. Thecompany is seeking partners for these regional efforts as well.

Otsuka's initial European steps will follow on the heels ofcommercial introduction of its 1.5-tesla OE 1.5 SI system in theAmerican market. FDA 510(k) clearance for sale of the $1.15 millionhigh-field system was granted last month.

Although Otsuka Electronics is owned by Otsuka Pharmaceuticalof Japan, its MRI development and manufacturing efforts are U.S.-based.The vendor made a strategic decision to build its technical reputationfirst in the U.S. before branching off to other global markets,Ariatti said.

"Otsuka recognized that the U.S. is the world leader inMRI," he said. "Although the MR market is depressedin the U.S., you can't capture the rest of the world's marketsunless you show that your product (is accepted as) top qualityin the U.S. You have to start here."

Ariatti was promoted last month from western regional salesmanager to head up Otsuka's sales and marketing effort. He isa medical imaging veteran with experience at EMI, Philips, MPDIand Toshiba. Prior to joining Otsuka in 1991, Ariatti was directorof MRI marketing for Toshiba America Medical Systems.

Kontron president Vincenzo Morelli brings a wealth of MRI experienceto the European effort, Ariatti said. Morelli was a former presidentof GE Medical Systems Europe and served as the first presidentand CEO of GE-CGR, following GE's acquisition of Thomson-CGR (SCAN8/5/87 and 9/14/88).

Supporting the regional launch from Otsuka's side will be Europeangeneral manager Leonard Fass, who joined the firm last year fromGE Medical, where he served as CT and MRI sales manager for Europe(SCAN 2/10/93).

Kontron, an ultrasound manufacturer, has not yet had an MRIoffering, Ariatti said.

"They are interested in marketing and distributing MR,"he said. "The agreement is good for both companies."

The FDA's thumbs up last month was not Otsuka's first, althoughit does mark the company's entrance into the market, he said.Otsuka made a decision not to sell or install its original MRIsystem, which used insertable gradients for specialized echo-planarimaging applications. That systems was 510(k)-certified in 1992.Otsuka's existing four installations all use the newer technology.

Although the insertable gradients could still become part ofa future upgrade, they did not perform as well as expected. Otsukaalso decided to focus on providing routine high-field imagingat a reduced cost, Ariatti said.

Abandoning the insertable gradient concept allowed Otsuka toreduce the system's list price by $100,000. The vendor added activelyshielded gradients last year and will soon add new acquisitionelectronics, fast spin echo and MR angiography. Further 510(k)clearance will be required for MRA.

Otsuka is developing a whole-body RF coil, which the firm expectswill be patented. Otsuka will also be collaborating with anothercompany on the development of a new EPI capability. An announcementregarding the EPI program should come within the next three months,Ariatti said.

ATL approaches ultrasound tissue characterization

ATL appears poised to open a new frontier in ultrasound. The Bothell,WA-based company plans to submit a premarket approval (PMA) applicationto the Food and Drug Administration for the use of its HDI (high-definitionimaging) technology to differentiate malignant from benign breastmasses.

Once its PMA application is filed, ATL will be the first ultrasoundvendor to request FDA clearance for the use of ultrasound to characterizesolid breast lesions. The vendor is seeking fast-track FDA approvalof the technique.

Tissue characterization could become a major new applicationfor ultrasound, providing clinicians with a noninvasive way todifferentiate suspicious masses.

Vendors and physicians have long sought what some have calledthe holy grail of ultrasound: the ability to produce images indicatingtissue condition at the cellular level, thus reducing the needfor biopsies subsequent to scanning.

To support its PMA, ATL sponsored a two-year, 14-center clinicalstudy in the U.S., Canada and Europe. The results were presentedat last month's Radiological Society of North America meetingby three clinical investigators involved in the study. They wereDr. Kenneth J. Taylor, chief of ultrasound at Yale University;Dr. Ellen B. Mendelson, director of the Breast Diagnostic ImagingCenter of Western Pennsylvania Hospital in Pittsburgh; and Dr.Christopher R. B. Merritt, radiology chairman at the Ochsner Clinicin New Orleans.

According to the investigators, premium ultrasound scannerscan be useful in reducing the number of biopsies performed onbenign masses. In the study, investigators used ATL Ultramark9 HDI scanners and L10-5 broadband linear-array probes to examine1077 women referred for biopsy because of an abnormal mammogramor a suspicious lump in the breast. Cysts, which can be differentiatedfrom solid masses with non-HDI technology, were excluded fromthe study.

With the ultrasound technique, clinicians were able to determinethat 400 women, or 37%, had benign breast masses. If these masseshad not been biopsied, the cost savings would have been between$500,000 and $1.5 million, according to the study.

The investigators discovered that ultrasound's sensitivitywas as good as or better than mammography. Ultrasound detectedover 98% of all breast masses, compared to 97% for mammography.Ultrasound missed six cancers, three of which were carcinomasin situ considered to be benign on mammograms, and one of whichwas determined to have been misread by investigators.

ATL commissioned the study shortly after the introduction ofHDI in 1991 (SCAN 4/24/91). Feedback from clinical investigatorsat the time indicated that the technology's improved resolutionenabled clinicians to visualize the structural characteristicsof small tumors much more clearly, according to Richard Tabbutt,director of the breast lesion study at ATL.

ATL's study used specific criteria for characterizing suspiciousmasses, Tabbutt said. The criteria for malignant lesions includeda poorly defined border, irregular margins, heterogeneous texture,hypoechoic tissue and central shadowing, and a length-to-widthratio that is less than one, with architectural distortion. Thecriteria for benign lesions included linear, well-defined margins,a homogeneous texture, edge shadowing or enhancement, and a length-to-widthratio greater than one.

ATL is in the process of applying for a PMA for using HDI tocharacterize solid breast masses. ATL opted to go the more rigorousPMA route rather than apply for 510(k) clearance. Negotiationswith the FDA indicated that the agency probably would not grantthe technique 510(k) clearance because it is unlike anything onthe market, Tabbutt said.

If ATL receives approval for the application, the company willbe able to promote HDI's capability to characterize solid breastmasses, Tabbutt said. The PMA process normally takes over 20 months(see story, page 5), but ATL is applying to get its PMA on theFDA's fast-track review process.

Fast-track review of life-saving devices was instituted lastyear as part of a reform of the agency's device approval process(SCAN 7/14/93). Fast-track review should cut the PMA's reviewtime to 11 months, Tabbutt said.

If the PMA is approved, ATL expects that clinicians will useHDI as an adjunct to mammography in selecting patients for biopsy.While many practicing mammographers might be reluctant to usethe technique on a regular basis because of its novelty, it hasconvinced the investigators in the study.

"Can this quality of ultrasound be used to eliminate unnecessarybiopsies?" Merritt asked at the RSNA presentation. "Ouranalysis of the data indicates that it can. We are prepared toparticipate in a study to directly implement the results of thisstudy in our practices."

The investigators also pointed out that characterization ofsolid masses should be limited to premium ultrasound equipmentusing high-frequency probes. ATL's L10-5 transducer is a smallparts and vascular probe with a broadband frequency range of 10to 5 MHz.

© 1994

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