French device company, The MEDICREA Group announced the company has received 510(k) clearance from the U.S. FDA for UNiD™, the world’s first patient-specific spinal osteosynthesis rod.
It’s NASS week in the U.S. (National Association of Spinal Surgeons) so companies are clamouring for a bit of the limelight in which to bathe their news. One such, Medicrea has its very own world first with the news that the FDA has cleared its uniquely customized spinal rod, and that a first U.S. implant has been performed.
Spinal Deformity Market
According to the National Scoliosis Foundation, an estimated six million people in the U.S. have scoliosis, patients making more than 600,000 visits to private physician offices each year. An estimated 38,000 patients undergo spinal fusion surgery. Adult spinal deformity surgery is likely to increase in frequency with as much as 32 percent of the adult population suffering from scoliosis and a prevalence of 60 percent among the elderly. Hospital costs of adult spinal deformity surgery can exceed $100,000 per patient.
Revisions and reoperations place a large financial burden on the health care system, increasing the average cost of adult spinal deformity surgery by more than 70 percent. Indeed the market for revision surgeries is growing at a significant rate because of the number of corrections performed with approximation errors and misalignment over the past 20 years.
Spinal Deformity Surgery
The surgical approach to correcting spinal deformities is most commonly the insertion of spinal rods, which require bending to create an anatomically suitable curvature. This has, until now, required surgeons to use a bending device, known as a French bender, supplied in all instrument kits to bend spinal 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.
A new technological approach may be about to change all that however. Headquartered in France, Medicrea specializes in the development of personalized implants produced for a patient’s specific need in the treatment of spinal pathologies. The company has developed UNID, which 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. The UNiD rod system carries CE mark approval and has been successfully implanted in over 100 patients in Europe. The real-time support team, the UNiD Lab, provides a seamless process by which surgeons preoperatively analyze, design and order the patient-specific rod. The UNiD 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 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 precisely manufactures the implantable rod and delivers it within 5 working days.
The benefits of a pre-prepared, precisely customized implant are perhaps obvious, but in essence:
- Surgeons can now be certain of implanting spinal fusion rods that are precisely adapted to the patient because UNiD rods are personalized and accurately curved using a design established by the surgeon during the pre-operative planning phase.
- Elimination of need to manually contour a rod during surgery: No more 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
- It allows surgeons to plan and then execute their operating strategy without compromises or approximation errors.
- It reduces the amount of time patients spend in the operating room, which directly impacts infection rate and quality of recovery.
- It improves their success rate in terms of global sagittal patient alignment. 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.
“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, 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,” said Frank J. Schwab, MD, a renowned orthopedic surgeon and spinal deformity expert, who performed the first customized UNiD rod surgery in the U.S. today.
“Medicrea’s groundbreaking UNiD patient-specific rods include the most current clinical data and software development along with the latest in personalized production and industrialization to revolutionize how spine surgery is performed. UNiDTM rods provide surgeons a very precise surgical method, supporting better patient care and improved economic outcomes,” said Denys Sournac, Founder, CEO and Chairman of Medicrea and added “FDA approval of UNiD is a major milestone for Medicrea. We started working closely with the FDA nearly 2 years ago on that strategic approval and this newly obtained clearance marks the culmination of years of research and surgery planning to bring a patient-specific spine implant to market, as well as the beginning of a new exciting era in spine surgery.”
The software component has been developed by healthcare IT company Nemaris. Virginie Lafage, PhD, Co-Founder of the company stated; “When we created Surgimap in 2008 our primary goal was to provide a research tool for surgeons to plan, measure and review their results. 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. It would not have been possible without such collaboration.”
Source: The Medicrea Group, Business Wire