It doesn't take an orthopedic surgeon to figure out that an X-ray image taken with the patient in a standing position using a lower-dose of radiation would offer significant benefits for both patient and physician, particularly when examining spine and joint alignment.
Thus, biospace med (Paris, France/Marietta, Georgia), developer of the EOS ultra-low dose 2D/3D orthopedic X-ray imager, reported last week that it has filed a 510(k) application with the FDA seeking clearance to market EOS in the U.S.
The filing comes on the heels of the company's obtaining for the system the CE mark and approval from the Health Canada Medical Device Bureau.
In addition, the company said its first two commercial installations have been completed and are now operational in Bordeaux, France, and Pecs, Hungary. Four other Canadian and European hospitals have been involved during the R&D phase of development and performed more than 3,000 images of both adult and pediatric cases.
The EOS ultra-low dose 2D/3D is based upon a patented particle detector technology for which French physicist Georges Charpak received the Nobel Prize in Physics in 1992, biospace med said. This detector, which is designed to allow images to be obtained with a lower dose of radiation, is part of a system that is capable of very long-length digital imaging, permitting full-body, uninterrupted digital imaging with a single scan, according to the company.
With EOS, the patient stands in the imager and a vertical drive mechanism moves a "C" arm down the height of the patient, or any desired length. The "C" arm contains two separate imaging systems capable of simultaneously capturing both a frontal and side image.
The highly sensitive X-ray detector enables low-dose image capture, creating a "head to toe" image within roughly 20 seconds for an adult and about half as long for shorter pediatric patients. The fully digital system produces a front and side view of the patient, which is instantly available for viewing. Unlike standard X-rays, there is no film, no need to adjust for distortion and no need to digitally stitch together multiple images, the company said.
Richard diMonda, biospace med's VP of strategic marketing, global, told Diagnostics & Imaging Week that EOS differs in several respects from a traditional X-ray or CT.
First, he said that because the imager consists of two X-ray hands and two detectors at right angles to each other, and the patient is standing in an upright, weight-bearing position, the image is "not distorted as is the case with most any other X-ray system."
The EOS imager also is able to capture longer length images, and subjects the patient to a much lower radiation dose. Whole body, standing-position imaging is especially valued by orthopedic surgeons when examining spine and joint alignment, diMonda said.
Additionally, the EOS imager addresses three primary problems associated with CT scans, diMonda said.
One, CT scans are not taken with the patient in a weight-bearing position, which, particularly for orthopedic surgeons, does not provide the doctor with the right information.
Second, CT uses a "very high dose" of radiation, he said. Third, he said, a CT scan can be quite costly.
"This technology offers a less expensive image at a much lower radiation dose, with new information being provided," diMonda said.
The lower-dose of radiation is particularly important, diMonda said, among pediatric patients with spine deformities, such as scoliosis, who have to be imaged a few times a year. Children are much more sensitive to the harmful effects of radiation, the company noted.
A U.S. Government study, to be published next year, determined that the per-capita radiation dose from clinical imaging exams has risen by 600% between 1980 and 2006, with a major contributor being CT exams, those numbers increasing over 20 times during this period, according to the company.
But low-dose radiation is far from being the only benefit of the EOS imager, according to Joe Sardano, the company's VP of sales in the U.S.
"Ultimately we think this system and the information it provides beyond just plain images is going to change orthopedic surgical outcomes," Sardano told D&IW. "There's a lot more to the product's benefits than just the lower dose."
diMonda said biospace med has developed software to generate a 3D skeletal image from the two planar images, without subjecting the patient to more image-taking, and thus, more radiation.
"When it is doing the 3D rendering the system actually identifies the anatomic name of each bone … the physician pushes a button and derives from that literally hundreds of calculations that would have taken him a very long time to do manually," diMonda said.
The advanced workstation, which generates the 3D skeletal image, is not part of the company's 510(k) submission, it said, and is currently not available for sale in the U.S.
diMonda said the company's historical origin began with Charpak particle detector which led to the creation of Biospace Lab, which developed a series of small animal imaging systems. Following the creation of Biospace Lab, Charpak met spine specialist Jean Dubousset, who could see the possible benefits of Charpak's particle detector. Together, Dubousset and Charpak developed a system to image humans, which would also address some of the limitations of traditional X-ray imaging and CT scans.
"From the start they wanted to have a 3D reproduction in a very low dose of radiation exposure with the patient in a weight-bearing position," diMonda said.
biospace med is venture-backed by a pool of investors led by Edmond de Rothschild Investment Partners.