Siemens makes European launch of digital spot mammography device

Vendor must play catch-up with Trex and Fischer

Siemens is hoping that technical innovation will help compensate for a late arrival on the market for digital spot mammography systems. The German vendor last month launched Opdima, a new digital spot device designed for use with its Mammomat 3000 mammography system.

Siemens rolled out Opdima at a press conference in Stockholm, Sweden, where the device is being manufactured. Opdima was displayed as a work-in-progress at the most recent meetings of the European Congress of Radiology and the Radiological Society of North America. Opdima shipments are scheduled to begin in Europe in May.

Opdima's range of applications includes digital high-resolution spot imaging, localization procedures, and digital stereotactic biopsy. It consists of a cassette that includes a 49 x 85-mm third-generation charge-coupled device (CCD) detector, and a workstation. The company has filed for Food and Drug Administration clearance for Opdima, which could be available in the U.S. by the end of June.

Opdima will encounter a crowded market in the U.S., which makes up a third of all mammography sales in the world. Fischer Imaging received FDA clearance for its digital spot mammography system in 1992, and Lorad followed a few months later, with Bennett X-Ray gaining clearance for its version in 1994. Nor will Siemens get much help from its installed base, as the company's U.S. market share is in the 6% range. Siemens is hoping that a reorganization of its U.S. sales force will lead to a doubling of mammography sales.

Opdima's prospects are brighter in Europe, however. Siemens has 20% of the European market and a worldwide total of over 5500 mammography units installed in 60 countries. The company will not disclose its sales targets for Opdima, but Bjarne Lundholm, marketing manager of the mammography division, said that he expects "tremendous interest" based on its ECR showing.

While Opdima is not the first digital spot system to arrive on the market, Siemens believes its technology is ahead of its rivals. The CCD detector allows data to be displayed at a resolution of 2048 x 3584 pixels, and the cassette is only 15 mm thick. First-generation optical systems and second-generation fiber-optic reducer or taper systems, by contrast, use smaller CCDs.

"By using the largest CCD detector available in the industry we can eliminate all components that have a negative impact on image quality," Lundholm said. "The technology also allows us to build a detector with an exceptionally compact design."

Siemens claims that Opdima's digital detector cassette avoids the loss of light that occurs through optics or tapers and provides better image quality, with a higher signal-to-noise ratio and resolution of more than 10 lp/mm. Opdima's workstation offers instant viewing, image postprocessing, magnification and filtering of images, automatic calculation of needle coordinates, and networking and archiving through the DICOM 3.0 standard.

Opdima has been beta-tested at two sites, in Sweden and the U.S. Clinical trials on digital spot mammography are under way at the Medical College of Virginia in Richmond, with a stereotactic biopsy evaluation to begin in May.

Early findings from the trial, which involved looking at patients who have abnormal screening mammograms, suggest that digital imaging allows earlier detection of smaller breast cancers and can prevent unnecessary biopsies, said Ellen Shaw de Paredes, a professor of radiology at the Medical College of Virginia. She believes Opdima is an improvement on competitors' systems.

"From our experience so far, the image quality is on a different level," de Paredes said.

The list price of Opdima will be around $120,000 at current exchange rates. The system will be manufactured at Siemens' mammography division in Solna, on the outskirts of Stockholm.

Opdima's launch inevitably sparked interest in Siemens' plans for full-field mammography imaging systems, which could be used for screening, clearly a far larger market than digital spot mammography. Fischer and the Trex Medical companies, Lorad and Bennett, are believed to be close to filing for FDA clearance of their full-field systems, but when such a device will reach the market is anyone's guess. Siemens displayed a panel on a full-view detector at last year's RSNA meeting.

Lundholm declined to elaborate on the company's plans for full-field digital breast imaging, other than to say that problems remain with cost and the display and storage of images.

"All the manufacturers are talking about full-field systems, but they are all works-in-progress and all use different approaches," Lundholm said. "We are investigating all these approaches but at the moment we can see no ideal solution. The industry needs at least two years to make such systems commercially available."