The Medicrea Group, a Lyon, France orthopedic implant company, has launched in Europe “the world’s first patient-specific spinal osteosynthesis rod system.” Spinal surgeons in France have successfully implanted the company’s UNiD rods into 43 patients with severe spinal deformities. According to the firm’s press release, the implants are pre-contoured using X-rays and the firm’s proprietary software so they accurately restore the sagittal alignment specific to each patient.
“This unique new technology provided by Medicrea will make it possible to eliminate the need for surgeons to manually bend spinal rods in the operating room during the surgery, ” said Denys Sournac, company chairman and CEO. “I fully believe this precise new way of analyzing, planning and designing patient-specific implants will significantly reduce the need for a patient with spinal deformations to undergo a subsequent operation requiring a number of vertebrae to be realigned.”
Vincent Fiere, M.D., an orthopedic surgeon at the Jean Mermoz hospital in Lyon carried out the first surgical operation using UNiD on September 18, 2013. Commenting on that experience he said, “I initially thought that the patient-specific rod was too short and overly curved. But, when I held it near the spine and then implanted it, I realized that it was simply perfect. The rod fused with the spine and allowed me to carry out the precise surgical reduction I had planned with the software that analyzes the patient’s X-rays a few days beforehand.”
According to Medicrea Group officials, until now, surgeons had no alternative but to use a bending device supplied in all instrument kits to bend the rods manually. This manual rod-contouring process involves estimating the curve using pre-operative X-rays displayed on a wall in the operating room. With UNiD, surgeons can be certain of implanting spinal fusion rods that are precisely adapted to the patient because UNiD rods are personalized and accurately curved using a design established by the surgeon during the pre-operative planning phase. Officials believe use of the new rod will eliminate the risk of rod breakage and will save time in the operating room.
The UNiD rod is available in two alloys (titanium TA6V ELI/cobalt chromium) and two diameters (5.5 mm/6 mm) which match global standards. Medicrea Group officials expect to receive FDA clearance to market UNiD rods in the United States by the end of the first half of 2014.
