Medicrea has received 510(k) clearance from the US Food and Drug Administration (FDA) for UNiD, the world’s first patient-specific spinal osteosynthesis rod. The technology is currently being premiered at the 2014 North American Spine Society (NASS) Annual Meeting. The first US patient has now undergone surgery to have personalised UNiD rods implanted in New York.
UNiD features a software tool to help surgeons preoperatively plan their surgery and order customised, industrially-produced rods to fit the specific spinal alignment needed for each individual patient. UNiD eliminates the need to manually contour a rod during surgery, providing surgeons with a precisely aligned rod prior to surgery and reducing the amount of time patients spend in the operating room, directly impacting infection rates and quality of recovery.
“By providing rod customisation, UNiD allows surgeons to precisely execute their preoperative plan and frees them from the antiquated technique of freehand bending, ensuring individual patients receive the most accurate and effective treatment,” says Frank J Schwab, a renowned orthopaedic surgeon and spinal deformity expert, who performed the first customised UNiD rod surgery.
The UNiD rod system, which has been successfully implanted in over 100 patients in Europe, offers a real-time support team, the UNiD Lab, that provides a process by which surgeons preoperatively analyse, design and order the patient-specific rod. The UNiD plug in is embedded into the Surgimap software, and provides surgeons an option for ordering patient-specific rods. After the planning process is complete, the order is transferred to the UNiD Lab, which processes the request and industrially produces and labels the rod specifically for the patient. As soon as the surgeon validates the rod’s design in the UNiD application, Medicrea manufactures the implantable rod and delivers it within five working days.
Virginie Lafage, co-founder of Nemaris, says tha his company collected data showing that “62% of patients remained sagittally malaligned after surgery. This was occurring not because of a lack of skills, but because surgeons have not had the best tools at their disposal. Our collaboration with Medicrea is an important step forward for spine surgery. Combining our software platform with Medicrea hardware solution was necessary to bring a solution to surgeons and the patients they treat.”
The primary benefit of UNiD is that is it allows surgeons to plan and then execute their operating strategy without compromises or approximation errors. Until now, surgeons had no alternative but to use a bending device, known as a French bender, supplied in all instrument kits to bend the rods manually. This manual rod-contouring process involves estimating the curve in a very empirical manner using preoperative x-rays displayed on a wall in the operating room. Significant error and variability exist with that approach. Medicrea’s new process eliminates the intraoperative use of a bending device, which creates indentations, or notches, in the rod. Such notches are an acknowledged cause of rods breaking postoperatively, which can occur in patients – especially adults with severe spinal deformities.
With the free UNiD application in the Surgimap software, spine surgeons have access to the most recent scientific data available on the parameters necessary to determine and restore sagittal alignment for each patient. Furthermore, surgeons can save time and be more efficient in the operating room as by eliminating the manual bending of rods during surgery. This is significant as infection rates and the quality of a patient’s recovery are directly linked to the duration of the surgical procedure.
UNiD patient-specific rods are universal implants available in two alloys (titanium TA6V ELI/cobalt chromium) and two diameters (5.5mm/6mm). UNiDnaturally fits into the PASS LP thoraco-lumbar fixation system, which is used by spine surgeons in 35 countries, and notably in the United States where the product accounts for the majority of Medicrea USA’s sales.