Medicrea has received US Food and Drug Administration (FDA) clearance for UNiD IB3D patient-matched interbody cages which completes its UNiD ASI (adaptive spine intelligence) platform technology.
UNiD IB3D patient-matched interbody cages are 3D-printed titanium implants which allow customisation of the cage dimensions, features and endplate morphology. According to Medicrea, it is the first time that this level of customisation is commercially available on the spinal device market.
The cages are specifically defined to precisely match the optimal patient’s surgical and anatomical requirements, determined by the UNiD LAB engineers during the pre-op planning phase, Medicrea said in a press release.
Through 3D reconstruction of the spine, the engineers map out the exact anatomy of each vertebrae endplates. They then design the ideal cage to restore proper height and angulation but also to offer an optimised surface contact between the implant and the vertebrae endplates in order to improve stability of the instrumented segment and reduce subsidence.
Denys Sournac, chief executive office and founder of Medicrea, said: “Until now, the only FDA-cleared patient-matched implants were limited to cranioplasty implants. These are mainly aesthetic and do not bear any weight. UNiD IB3D patient-matched interbody cages are the first patient-matched implants FDA-cleared for load bearing applications, specifically designed for spine surgery.”