Surgical technologies developer the Medicrea group has launched the UNiD, the world's first patient-specific spinal osteosynthesis rod system in Europe.
French spinal surgeons have successfully implanted the customised UNiD rods into 43 patients to correct severe spinal deformities.
The first surgical operation using UNiD was carried out on 18 September 2013 by Dr Vincent FIERE, an orthopaedic surgeon at the Jean Mermoz hospital in Lyon, France.
Dr FIERE and his colleagues have performed more than ten surgeries using the UNiD rods to date.
These customised implants are specifically pre-contoured using x-rays and proprietary software to enable the surgeons to perform a more precise procedure for each patient.
The UNiD system includes a software application and real-time supporting team that provide a seamless process that surgeons preoperatively analyse, design, and order the patient-specific rods.
MEDICREA chairman and CEO Denys Sournac said this 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.
"I fully believe this precise new way of analysing, 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," Sournac said.
The UNiD customised rod offers surgeons to execute their operating strategy without any comprises or approximation errors. Surgeons can improve their success rate in terms of sagittal equilibrium.
In addition, the UNiD customised rods not only allow the surgeons to reduce the risk of the rod breakage but also help them save the procedural time and improve efficiencies in the operating room.
The UNiD rod is a universal implant available in two alloys (Titanium TA6V ELI/Cobalt Chromium) and two diameters (5.5mm/6mm), which match global standards.
According to the company, it fits into the range of implants that make up the PASS LP thoraco-lumbar fixation system, present in a worldwide market segment estimated at $3.6bn.
The PASS LP system is already used by numerous spine surgeons in 35 countries, and notably in the US where this product accounts for the majority of company's sales.
The company currently expects FDA clearance to market UNiD rods in the US by the end of mid-2014.