Surgeons now have a much more realistic image to use when planning spine and knee procedures with the FDA's 510(k) clearance this week of biospace med's (Paris/Marietta, Georgia) X-ray imaging system, the first that allows patients to stand up during the process and produces 3-D images.

"The big benefit is that it's the first weight-bearing 3-D reconstruction of X-rays," Richard diMonda, biospace med's VP of strategic marketing, global, told Medical Device Daily. "There is no other 3-D X-ray imaging system available. That's unique. It provides an advantage of helping to manifest disease better by having the patient in a weight-bearing position so that surgeons can make measurements for surgical planning in that position."

A surgeon's current option for obtaining 3-D images is a computed tomography (CT) scan, which must be pieced together and doesn't reflect a weight-bearing position.

The EOS X-ray imager along with its image workstation, sterEOS, enables 3-D skeletal reconstruction in a matter of minutes. EOS is best suited for clinical indications such as spine pathologies and hip and knee arthropathies, where a weight-bearing assessment is necessary to ensure optimal treatment.

diMonda said biospace med developed software to generate a 3-D skeletal image from the two planar images, without subjecting the patient to more image-taking and more radiation.

Imaging patients in a weight-bearing position allows the surgeon to factor in issues concerning posture, balance and patient stances. "None of these things are evident in a supine X-ray like that made in a CT scanner," diMonda said. "The difference between a normal X-ray system is that you can measure lengths and angles in 3-D eliminating the errors associated with planar imaging distortion. Our images enable you to make a one-to-one undistorted image."

The $500,000 X-ray system can capture head-to-toe images of patients in a standing, weight-bearing position with a reduction in radiation dosage — up to 10 times less than conventional X-rays and up to 1,000 times less than a computed tomography scan.

"EOS is especially helpful in any situation where patients want to limit their exposure to radiation, and also in situations where long-length, weight-bearing images are needed," said Jean-Charles LeHuec, MD, of Bordeaux Spine Center at Pellegrin University Hospital (Bordeaux, France). "The full-length, weight-bearing imaging capabilities of EOS are able to provide physicians with a global assessment of balance and posture and now, with 3-D, an assessment of the relative positioning of each vertebra, thereby enabling better preoperative assessment."

The Bordeaux center is the site of one of the first installations of biospace med's EOS. diMonda said three other systems are installed in Canada and one in New Jersey.

"We're working with a number of institutions to get more installations and help us to get additional experience with the system," he said, adding that although EOS operates similar to other imaging equipment, the 3-D image reconstruction requires a bit of operator training.

EOS is based on a particle detector technology for which French physicist Georges Charpak received the Nobel Prize in physics in 1992, according to biospace med.

The company said that as its commercialization efforts ramp up, reimbursement will not be a challenge since all existing standard X-ray reimbursement codes can be used, including a special 3-D reconstruction code.