French spinal company, the MEDICREA group, has announced the European launch of the UNiD, the world’s first patient-specific spinal osteosynthesis rod system.
When implanting structural rods in order to correct or arrest progress of spinal curvature, surgeons have hitherto needed to use a bending device supplied in all instrument kits to bend the rods manually to the desired shape. This process involves estimating the curve in a very empirical manner using pre-operative X-rays displayed on a wall in the operating room. It is a time-consuming, iterative process that carries the potential to be inaccurate and also impart damage to the rods, which have been known to break post-operatively.
Medicrea concluded that in this day and age, imaging and computer technology could bring something new to the table. And so it turned out, with the development of the UNiD customised rod concept. The UNiD system includes a software application and a real-time support team that provide a seamless process by which surgeons preoperatively analyze, design, and order the patient-specific rods. The way it works is that the surgeon sends data to Medicrea, derived from X-Rays and the proprietary software. Medicrea then creates its design, which is forwarded to the surgeon and once validated using the SURGIMAP UNiD application, the company precisely manufactures the implantable rod and delivers it within a week.
The UNiD customized rod offers the major advantages of being accurate, improving success rate in terms of sagittal equilibrium by interfacing to the most recent scientific data available on the parameters necessary to determine and restore sagittal alignment for each patient.
Furthermore, by being pre-contoured using a controllable and reproducible industrial process there is no longer a need for the intraoperative use of a bending device, which creates indentations, or notches, in the rod and can induce breakage.
Ultimately though, by having a pre-prepared rod to hand, surgeons can save time, procedure duration can be shorter, with all the attendant benefits in terms of outcome and efficiency.
Surgeons in France have successfully implanted the customized UNiD rods into 43 patients with severe spinal deformities.
The first surgical operation using UNiD was carried out on September 18, 2013 by Vincent FIERE, MD, an orthopedic surgeon at the Jean Mermoz hospital in Lyon, a leading and recognized hospital that specializes in diagnosing and surgically treating spinal deformations. Dr. FIERE and a number of his colleagues have since performed ten more surgeries using the UNiD rods.
The system is now being rolled out in Europe, and FDA marketing clearance in the United States is expected at the end of the first half of 2014.
When discussing the very first UNiD surgery, Dr. FIERE 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. That day, I was visited by an American surgeon in the operating room, and we both felt that a major step had been made in spine surgery. UNiD provided us with a perfect profile, strictly in line with the operation we had planned in order to restore the patient’s ideal spinal balance, taking into account the anatomical specificities and pathology.”
“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, Chairman and CEO of MEDICREA. “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.”
“Spine surgeons will now be able to use a simple technology enabling them to accurately perform the correction that they have planned beforehand using the latest published scientific research,” Sournac said. “I am totally convinced that this new and more data-driven and industrial approach will become, in the years to come, a benchmark in spine surgery.”
Source: Medicrea, Business Wire