FDA Clears Medicrea’s Spinal Osteosynthesis Rod In Time for NASS

The Medicrea Group has received 510(k) clearance from the U.S. Food and Drug Administration for its patient-specific spinal osteosynthesis rod, UNiD, in time for the product to premiere at the 2014 North American Spine Society (NASS) Annual Meeting taking place on November 12-15 in San Francisco, Calif. The UNiD system is already in use in Europe.

The software featured in UNiD is Surgimap, created by Nemaris Inc. The program is designed to help surgeons preoperatively plan their surgery and order customized, industrially-produced rods to fit the specific spinal alignment needed for each individual patient. The system does not require the surgeon to manually contour a rod during surgery, which the company reports provides surgeons with a precisely aligned rod prior to surgery and reducing the amount of time patients spend in the operating room, which directly impacts infection rate and quality of recovery.

“Understanding and restoring sagittal alignment is key towards providing better patient outcomes and preventing the need for reoperations, a major factor in rising health care costs,” said Frank J. Schwab, M.D., an orthopedic surgeon and spinal deformity expert who performed the first customized UNiD rod surgery in the U.S. on Nov. 10. “By providing rod customization, 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. Having a more precise, personalized rod ready before even stepping foot in the operating room is a game-changer for spine surgery.”

The UNiD system comes with a real-time support team, the UNiD Lab, that provides a process by which surgeons preoperatively analyze, design and order the patient-specific rod. Surgeons can order the patient-specific rods via the UNiD plug-in, proprietary to Medicrea, which is embedded into the Surgimap software. 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.

“When we created Surgimap in 2008 our primary goal was to provide a research tool for surgeons to plan, measure and review their results,” said Virginie Lafage, Ph.D., Co-Founder of Nemaris, developer of Surgimap. “As we collected data we noticed a startling trend: 62 percent of patient 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 core competency, our software platform, with Medicrea’s hardware solution was necessary to bring a cutting-edge solution to surgeons and the patients they treat.”

Medicrea will be displaying UNiD at booth #2231 at the Moscone Center during NASS.