Siemens Healthcare announced today that its tomosynthesis add-on for the MAMMOMAT Inspiration digital mammography system received FDA approval. The MAMMOMAT Inspiration with Tomosynthesis Option is a software upgrade that reconstructs multiple 2-D breast images into an approximation of a 3-D image.
In the tomosynthesis mode, the X-ray tube moves in a circular motion around the patient’s breast, acquiring an image every two degrees. It simultaneously moves through a 50 degree angular range and then produces 25 projections reconstructed as 3-D images. Other tomosynthesis solutions on the market have angulation arcs up to 20 degrees.
The only other vendors with tomosynthesis solutions approved in the U.S. are GE Healthcare and Hologic. Siemens' tomosynthesis option has been in clinical use in Europe, Asia and South America since 2009.
"Patients have been educated that 3-D mammography does more than 2-D,” Jennifer Okken, senior manager of women’s health, told DOTmed News. “That encouraged us to introduce tomosynthesis here in the U.S. market because it is really proving, along with 2-D mammography, to increase the cancer detection rate.”
Conventional analog mammography and full-field digital mammography only display the 3-D structure of the breast on the 2-D level, which makes it more difficult for a physician to spot certain tumors since anatomical structures in the breast can be overlaid and as a result hide lesions. But since 2-D mammography is still the standard of care, the MAMMOMAT Inspiration system does both 2-D and 3-D mammography.
Once a large screening study is conducted in the U.S., showing the benefits of tomosynthesis, Okken believes it will become the standard of care. “I think it will take a bit of time. We need to run a large screening study in the U.S. similar to the ACRIN study we conducted for digital mammography — something that really shows, with all three vendors, what tomosynthesis can potentially do,” she said.
One of the challenges is that all of the systems with breast tomosynthesis on the market right now function differently. “The degree of angulation alone changes the detection rate, so you can’t replace screening mammography if one vendor doesn’t detect as much as the other vendors do,” said Okken.
But Okken said that it’s something all three of the vendors will work on in the future.