The new 3D-printed titanium implants facilitate customisation of the cage dimensions
The US FDA’s Center for Devices and Radiological Health (Credit: The U.S. Food and Drug Administration)
MEDICREA has secured approval from the US Food and Drug Administration (FDA) for its UNiD IB3D patient-matched interbody cages.
With the latest approval, the company has completed its UNiD adaptive spine intelligence (ASI) advanced software platform.
UNiD IB3D patient-matched interbody cages are 3D-printed titanium implants, which enables customisation of the cage dimensions, features and endplate morphology.
The new cages have been designed to precisely match the optimal patient’s surgical and anatomical requirements
MEDICREA has designed new cages to accurately match the optimal patient’s surgical and anatomical requirements, which were determined by the UNiD LAB engineers during the pre-op planning phase.
The engineers determine the exact anatomy of each vertebrae endplates via 3D reconstruction of the spine.
Later, the engineers will design the suitable cage for the restoration of proper height and angulation, as well as to provide an optimised surface contact between the implant and the vertebrae endplates to enhance the stability of the instrumented segment and reduce subsidence.
UNiD IB3D patient-matched interbody cages enables the surgeon to address geometrical inconsistencies of endplates and vertebral bodies, helping to improve surgical and clinical outcomes.
The company has used the UNiD ASI pre-operative surgical planning tool to design the UNiD IB3D patient-matched interbody cages.
The tool will help design precise patient-specific implantable devices and help streamline implant inventory in the operating room.
MEDICREA founder and CEO Denys Sournac 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.
“MEDICREA’s recent FDA-clearance reinforces its leading position in changing the spine industry by offering an alternative option for these very specific cases that did not have a personalized solution until now.”
In August 2019, MEDICREA secured FDA clearance for its TULIP GENESIS which completes its UNiD platform technology.