FDA clears world's first patient-specific spinal rod

The MEDICREA group, a company that specializes in the development of personalized implants produced for a patient's specific need in the treatment of spinal pathologies, has announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for UNiDTM, the world's first patient-specific spinal osteosynthesis rod. The technology will be premiered at the 2014 North American Spine Society (NASS) Annual Meeting taking place on November 12-15 in San Francisco. The first U.S. patient underwent surgery to have personalized UNiDTM rods implanted earlier today in New York.

UNiDTM features a user-friendly software tool to help surgeons preoperatively plan their surgery and order customized, industrially-produced rods to fit the specific spinal alignment needed for each individual patient. UNiDTM 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, 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. By providing rod customization, UNiDTM 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," said Frank J. Schwab, MD, a renowned orthopedic surgeon and spinal deformity expert, who performed the first customized UNiDTM rod surgery in the U.S. today.

The UNiDTM rod system, which has been successfully implanted in over 100 patients in Europe, offers a real-time support team, the UNiDTM Lab, that provides a seamless process by which surgeons preoperatively analyze, design and order the patient-specific rod. The UNiDTM plug in, proprietary to MEDICREA, is embedded into the Surgimap software, and provides surgeons a quick and efficient option for ordering patient-specific rods. After the planning process is complete, the order is transferred to the UNiDTM 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, PhD, Co-Founder of NEMARIS. "As we collected data we noticed a startling trend: 62 percent of patient remained sagittally malaligned after surgery [i]. 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. It would not have been possible without such collaboration."

The UNiDTM customized rod offers numerous benefits to surgeons and patients undergoing spine surgery.

• The primary benefit of UNiDTM 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 pre-operative X-rays displayed on a wall in the operating room. Significant error and variability exist with that approach. With UNiDTM, surgeons can now be certain of implanting spinal fusion rods that are precisely adapted to the patient because UNiDTM rods are personalized and accurately curved using a design established by the surgeon during the pre-operative planning phase with the Surgimap / UNiDTM software.

Additional advantages of UNiDTM include:

• Surgeons can improve their success rate in terms of global sagittal patient alignment. With the free UNiDTM 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.
• Surgeons can save time and be more efficient in the operating room. By eliminating the manual bending of rods during surgery, surgeons can significantly reduce operating time. This is an additional benefit, since infection rates and the quality of a patient's recovery are directly linked to the duration of the surgical procedure. As soon as the surgeon validates the rod's design in the UNiDTM application, MEDICREA precisely manufactures the implantable rod and delivers it within 5 working days.
• Surgeons can reduce the risk of spinal implant failure. The UNiDTM rods, customized for each patient, are pre-contoured using a controllable and reproducible industrial process. This 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.