Medicrea Releases Patient-Specific Spinal Rod System In Europe

The Medicrea Group, a France-based company that specializes in the development of surgical technologies for the treatment of spinal pathologies, today announced the European launch of the UNiD, the a patient-specific spinal osteosynthesis rod system.

Spinal surgeons in France have successfully implanted the customized UNiD rods into 43 patients with severe spinal deformities. These customized implants, which are specifically pre-contoured using x-rays and proprietary software, enable the surgeons to perfectly execute their surgical plans and 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 Chairman and CEO Denys Sournac. “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.”

The first surgical operation using UNiD was carried out on September 18, 2013 by Vincent Fiere, M.D., an orthopedic surgeon at the Jean Mermoz hospital in Lyon, France, a hospital specializing in diagnosing and surgically treating spinal deformations. Fiere and a number of his colleagues have since performed ten more surgeries using the UNiD rods.

“I initially thought that the patient-specific rod was too short and overly curved,” said Fiere, discussing the very first UNiD surgery. “When discussing the very first UNiD surgery, Fiere said, 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.”

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.

According to Medicrea, The UNiD customized rod offers four significant features: Surgeons can execute their operating strategy without any comprises or approximation errors; surgeons can improve their success rate in terms of sagittal equilibrium; surgeons can improve their success rate in terms of sagittal equilibrium; surgeons can reduce the risk of the rod breakage; surgeons can save time and be more efficient in the operating room.

“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.”

The UNiD rod is a universal implant available in two alloys (titanium TA6V ELI/cobalt chromium) and two diameters (5.5 mm/6 mm) which match global standards. U.S. Food and Drug Administration clearance for the UNiD rods is expected at the end of the first half of 2014.