The US Food and Drug Administration (FDA) has granted approval for French orthopedic medical imaging company EOS imaging's spineEOS, an online 3D planning software for spine surgery based on EOS stereo-radiographic 2D / 3D imaging.
With the approval, EOS can explore its options of introducing and marketing the product in the growing US spine market, particularly in the complex spine and thoraco-lumbar fusion surgery markets which treats 400,000 patients every year and represents more than $3bn in orthopedic implant value.
The company noted that the spineEOS can be administered to adults afflicted with degenerative or deformative spine conditions, as well as to pediatric patients with adolescent idiopathic scoliosis.
It enables surgeons to design a treatment plan to achieve optimal sagittal alignment from pelvic and vertebral 3D data obtained in the functional standing position from an EOS exam.
The planned surgery and virtual post-correction 3D anatomy can be used to precisely plan for the 3D shape and length of the spinal implants.
The plan can be shared with the patient prior to the operation, engaging the patient in the intended course of therapy, and can be accessed in the operating room through a custom planning report.
EOS imaging CEO Marie Meynadier said: "We believe that patients' spines are complex 3D systems that need a personalised 3D planning of the intended surgery.
"We're excited about the interest we've seen in our spineEOS planning software from surgeons inside and outside of our current installed base, as well as from our industry partners.
"We look forward to this next important step toward our broader goal of expanding our EOSapps planning software suite to better connect imaging to patient care."
Image: A diagram of the effects of Scoliosis. Photo: courtesy of BruceBlaus.