Company receives FDA clearance of sterEOS for lower limb disorders and deformities
Breakthrough features: 3D modeling in weight-bearing position at ultra-low dose
Company to exhibit at AAOS annual meeting (Booth #4111)
CAMBRIDGE, Mass., and PARIS--(BUSINESS WIRE)-- EOS imaging (www.eos-imaging.com) announced today that it has received FDA clearance of its sterEOS 3D orthopedic imaging workstation for use in lower limbs applications for patients 15 years and older.
For decades, radiologists, orthopaedic surgeons and rheumatologists have had to rely on a set of 2D x-ray images to help them imagine what a 3D skeletal image of their patient would look like. Now, the EOS workstation sterEOS can create a 3D rendering of a patient’s skeletal anatomy. Key surgeries such as hip and knee arthroplasties, previously planned for most patients from local and projected 2D images, will now benefit from weight-bearing, large size 3D images. Furthermore, the ability of EOS to provide clinical parameters necessary for certain hip and knee conditions will allow to avoid irradiating, costly and time-consuming CT exams prescribed in such cases.
“We are very pleased with this additional FDA clearance, as it will further fuel the market penetration momentum that we are achieving in the United States for our ultra-low-radiation-dose EOS orthopedic imaging system,” said Hervé Legrand, VP Sales & Marketing North America for EOS imaging. “Some of the most prestigious orthopedic centers in the world, such as Barnes-Jewish Hospital (St. Louis, Mo.), New York University (N.Y.), and the University of Iowa (Iowa City), have recently adopted EOS and sterEOS for their musculoskeletal imaging suites.
“This clearance is a great step forward for us as it is now allowing orthopedic surgeons specialized in lower limb disorders to have access to our unique technology. For the first time, orthopedists can retrieve patients’ highly accurate clinical parameters of the femur and the tibia in a weight-bearing position that will ensure optimal pre-operative and post-operative planning. This has not been possible until now,” added Mr. Legrand. “These breakthrough features underscore why EOS is developing as an entirely new modality in orthopedic imaging, with extremely low x-ray exposure to the patient — and efficient patient workflow for the physician,” said Mr. Legrand.
About the EOS product and the company EOS imaging
EOS was developed from a Nobel Prize-winning technology by a team of engineers, orthopedic surgeons and radiologists as a complete orthopedic imaging solution. EOS allows full-body imaging of patients that enables global assessment of balance and posture as well as a 3D bone-envelope image in a weight-bearing position, and provides automatically over 100 clinical parameters to the orthopedic surgeon for pre- and post-operative surgical planning. EOS is a total solution in orthopedic imaging available in the U.S. since receiving FDA 510(k) clearance. The company EOS Imaging has corporate headquarters in Cambridge, Mass. (185 Alewife Brook Parkway, Suite 410; toll-free: +1-866-933-5301), and Paris, as well as an office in Montreal, and is targeting a $2 billion orthopedic imaging marketplace.
Learn more at: www.eos-imaging.com.
CONTACT:
Ronald Trahan Associates
Ronald Trahan, 508-359-4005
APR
KEYWORDS: United States Europe North America France Massachusetts
INDUSTRY KEYWORDS: Health Hospitals Medical Devices Radiology
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