Planmed popularizes technology that pulls breast tissue into FOV

U.S. subsidiary enlists SourceOne to distribute MaxView

Screening exams miss up to 10% of cancers for many reasons. One occurs when breast cancer resides in tissue along the chest wall, outside the range of most conventional mammography systems. But this cancer need not escape detection. Planmed has come up with a technology that mechanically pulls tissue away from the chest wall and into the field-of-view.

MaxView allows up to 30% more tissue to be visualized, according to the clinical studies conducted by the Finnish company. Doing so increases the chance of lesion detection and, consequently, earlier cancer detection.

Early versions of the technology, which began appearing at clinical sites in the U.S. three years ago, have produced encouraging results. Iraj Khalkhali, a professor of radiological sciences at the University of California, Los Angeles, has documented cancer found with the Planmed system that had been missed by conventional mammography.

"We had a few patients who had cancers in the back of the breast and when we examined them with a conventional mammogram, we totally missed the cancer," Khalkhali said. "Only with MaxView were we able to see it."

At the Society of Breast Imaging biannual meeting April 12-13, Planmed launched the latest version of this technology, transforming it from an add-on for its standard Sophie Classic mammography system to an integral part of the new MaxView platform.

"We have redesigned the Sophie to incorporate the positioning technology into the MaxView so it operates and functions as a system," said Chris Oldham, director of North American sales at the Roselle, IL, division of the Helsinki, Finland-based Planmeca Group.

MaxView's isocentric C-arm and column are built to provide overall alignment with the patient. The breast is compressed, as with conventional systems, with upper and lower paddles. Unlike conventional systems, however, MaxView uses moving, disposable radiolucent sheets positioned on the paddles to pull breast tissue away from the chest wall and into the path of the x-ray exposure. More tissue can be imaged as a result, according to the company. The rolling effect of the sheets, which are activated using a foot pedal, also spreads tissue sideways, minimizing artifacts resulting from superimposed tissue. Optimal breast positioning can be achieved by independently manipulating the upper and lower sheets.

About one of every 10 breast cancers is located near the chest wall, according to the company. This tissue often escapes assessment because of the difficulty technologists have positioning the breast. MaxView achieves optimal positioning mechanically.

"When you see the breast coming forward, you know that more of the tissue is being imaged," Khalkhali said.

He estimates that the technology allows visualization of about 1.5 to 2 cm more of the posterior part of the breast.

Just as the company is transforming its product line to integrate the positioning technology, so is it changing the way it does business in the U.S. Previously, Planmed had relied on a nationwide network of independent dealers to market its mammography products. Their efforts resulted in the placement of just 50 systems in the U.S. Another 50 were installed through sales efforts outside the U.S.

In late March, Planmed hooked up with SourceOne Healthcare Technologies to sell its mammography units in the U.S. Sales could generate more than $30 million over the life of the three-year contract, according to the two companies.

Under the agreement, which took effect March 31, SourceOne has exclusive rights to sell Planmed's MaxView, as well as its mobile mammography product line, in about 90% of U.S. markets. (Planmed has retained several dealers in its previous network to handle equipment in about 10% of U.S. markets, Oldham said.) SourceOne, which distributes imaging equipment, supplies, and accessories and provides service in the U.S., will also distribute Planmed's line of mammography peripherals, including radiation screens, storage units, and biopsy needle guidance systems.

MaxView will be sold by a national sales organization dedicated to women's health. The distributor is now beginning to roll out MaxView, Oldham said. Planmed is working with the distributor to promote and sell the product.

The alliance with SourceOne was made possible when Hologic executives decided earlier this year not to renew an agreement with SourceOne to sell their Lorad mammography equipment. In a bid to increase control over product sales and improve margins, Hologic chose to build up its in-house sales and service staff (SCAN 2/19/03).

At the time, SourceOne was in the final stages of a corporate metamorphosis achieved through the merger of two large distributors: Diagnostic Imaging and Health Care Products (SCAN 1/22/03). Platinum Equity of Los Angeles acquired the two companies late last year. Today SourceOne has about 2300 employees operating out of 90 U.S. locations

Utilizing this extended network, Planmed executives hope to put MaxView into head-to-head competition with leading mammography systems. It has taken about a decade to get this far. The technology was first conceptualized in the early 1990s by researchers at Massachusetts General Hospital. The head of MGH research, Richard Moore, and Dr. Daniel B. Kopans, a professor of radiology at Harvard Medical School and director of the MGH breast imaging department, collaborated on the idea.

"We were seeing cases where we realized that the cancer would have been visible a year earlier if the breast had been better positioned," Kopans said. "The part of the breast where the cancer developed was not initially in the field-of-view."

The two men shopped the concept around the industry. Planmed was the only company that took them up on it, Kopans said.

Eventually the MaxView system will come in both analog and digital configurations. Planmed has struck a deal with Analogic for the Peabody, MA, company to supply an amorphous selenium detector for use in the system, Oldham said.

Much of the design work has already been done. Planmed expects to have a CE mark and begin selling the full-field digital system by early next year in Europe. Soon after, the company will apply for FDA approval.