Trex CE Mark gives European patients access to digital mammography before those in the U.S.

TDMS clearance is first for a full-field digital mammography device

Once again, Europeans will be the first to gain access to cutting-edge technology developed in the U.S. for digital mammography. This time, the technology involved is a full-field digital mammography system manufactured by Trex Medical of Danbury, CT. Trex this month received the CE Mark for its TDMS (Trex Digital Mammography System), which gives the company the right to sell the device throughout the European Union.

In obtaining the CE Mark, Trex will become the first company to commercialize a modern full-field digital mammography system. The positive European decision, however, underscores the regulatory struggle that is still going on in the U.S., where the Food and Drug Administration has been reviewing a 510(k) application regarding TDMS for the past 10 months.

"I am disappointed that the FDA has not acted on us," said Hal Kirshner, president and CEO of Trex. "If it is good enough for Europe, it should be good enough for the U.S."

The European decision could turn up the heat on the FDA to clear the Trex device. The agency has lagged behind its European counterparts on other new mammography technologies. One such technology is computer-aided diagnosis workstations: In that case, the FDA took more than a year longer than the Europeans in approving a CAD workstation developed by R2 Technology of Los Altos, CA (SCAN 7/22/98).

Digital mammography has become a centerpiece of women's health in recent years, because of its promise to allow earlier detection of breast cancer. Several women's advocacy groups with considerable political clout on Capitol Hill, are actively following the Trex situation.

"You can believe that I will ask for their help, if I don't hear from the FDA soon," Kirshner said. "I am going to ask for the help of anyone who can get this important modality to market."

One advocacy group that might help is the National Alliance of Breast Cancer Organizations (NABCO). Amy Langer, executive director, believes digital mammography should be commercialized in the U.S. She does not, however, cast the FDA in a negative role. Instead, she said, the FDA is helping through cooperative efforts with other agencies within the Department of Health and Human Services (of which the FDA is a part) to advance the technology.

"I do feel we are moving forward here in the U.S.," Langer said. "Although we are not at the place that Europe has reached, (digital mammography) certainly isn't something that has been ignored here."

Handling the 510(k) submission from Trex is the radiology branch within the Office of Device Evaluation (ODE). Robert Phillips, chief of the radiology branch, said the difference between the European and U.S. regulatory processes explains the time delay.

"The rules in Europe do not require prior demonstration of effectiveness," Phillips said. "The U.S. law is written such that you have to demonstrate safety and effectiveness before you go to market."

The FDA process has been slowed further by concerns about the efficacy of digital mammography, which led the agency some three years ago to develop a special guidance for reviewing the technology. In mid-August, the FDA hosted a meeting on digital mammography, during which the agency announced plans to revise the guidelines (SCAN 9/16/98).

The revision is not expected to affect the ongoing review at the FDA, which is already running much longer than expected. Typically, 510(k) reviews require just 90 to 180 days. The Trex application has been in process since Dec. 1, 1997. Since then, the agency has been actively addressing issues within the application in cooperation with Trex, according to Phillips.

Kirshner acknowledges that there has been interaction with the FDA, and he is hopeful that the outcome will be positive soon.

"We have complied and explained and answered all their questions," he said. "We are hopeful that we will get clearance prior to (the Radiological Society of North America meeting), perhaps any day now."

Targeting the installed base. Trex's TDMS uses a detector based on charge-coupled device technology to digitize x-rays and send them to a workstation for viewing. Full-field units are capable of capturing the entire breast in a single exposure, unlike digital spot mammography systems that have been marketed since 1992.

If and when cleared by the FDA, TDMS will be compatible with Trex's high-end conventional mammography systems developed by its Lorad and Bennett divisions, M-IV and Contour. Installed systems can be field-upgraded to digital, according to Kirshner. About 2000 of these units, half of which are M-IV and the other half a version of Contour, are in operation. All but 10% of these are located in the U.S., which means that most of the digital mammography devices sold into Europe will have to be new, integrated systems.

Whereas field upgrades promise at least some savings, European customers will have little choice but to pay between $400,000 and $500,000 for each new unit. The price is high if compared with conventional mammography equipment, but it is not excessive considering the prices of MR, CT, nuclear medicine, and even ultrasound scanners, Kirshner said.

Trex is preparing to kick off its European sales program. Company executives will coordinate European sales through its French subsidiary, Trophy Radiologie, which was acquired in April 1998. The company will use both a direct sales force and distributors. Both large and small hospitals in Europe, as well as imaging centers, have already expressed interest in the technology, Kirshner said, although no sales have closed.

In anticipation of receiving the CE Mark, the company began initial production for TDMS at Bennett's facility in Long Island, NY. Part of the initial start-up involved validation of software and production process according to standards set by European and U.S. regulatory agencies. The first commercial systems are expected to ship in November.

The CE Mark can be used as the foundation for gaining access to markets outside the EU, including most African and Middle Eastern countries. To gain this access, some minor additional requirements may have to be met. Clearing these regulatory hurdles will be the responsibility of Trex distributors in these countries.

"The FDA is being very careful that the protocol (for the clinical trials) is in compliance with generally accepted radiological procedures," he said. "We have had a positive dialogue with the FDA, and we anxiously and patiently wait for their clearance."