France's Medicrea Group said it has received FDA clearance for the world's first patient-specific spinal osteosynthesis rod, the UNiD, enabling physicians to order customized rods that match the spinal alignment of each patient.
|Dr. Frank Schwab|
Orthopedic surgeon Dr. Frank Schwab of the NYU Langone Medical Center performed the first customized UNiD rod surgery in the U.S. this week, according to the release.
"Understanding and restoring sagittal alignment is key towards providing better patient outcomes and preventing the need for reoperations, a major factor in rising healthcare costs," Schwab said in a statement. "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 rods are manufactured at the so-called UNiD Lab according to the physician's request via the Surgimap/UNiD software. Advantages of the product include a decreased risk of spinal implant failure, an improved success rate of global sagittal patient alignment, and greater efficiency in the operating room, according to the release.
|Medicrea CEO Denys Sournac|
"FDA approval of UNiD is a major milestone for Medicrea," said company CEO Denys Sournac in a statement. "We started working closely with the FDA nearly two 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."
Medicrea says the product has been successfully implanted in more than 100 patients in Europe.
- read the release