FDA Clears First Patient-Matched Spinal Interbody Cages

MEDICREA, pioneering the transformation of spinal surgery through artificial intelligence, predictive modeling and patient specific implants with its UNiD ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, has received U.S. Food and Drug Administration (FDA) clearance for UNiD IB3D Patient-Matched interbody cages, which completes its UNiD ASI platform technology.
 
UNiD IB3D Patient-Matched interbody cages are 3D-printed titanium implants which allow customization of the cage dimensions, features and endplate morphology. It is the first time that this level of customization is commercially available on the spinal device market, according to MEDICREA.
 
These 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. 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 optimized surface contact between the implant and the vertebrae endplates in order to improve stability of the instrumented segment and reduce subsidence.
 
With this new FDA clearance, MEDICREA offers a solution that does not only meet standard clinical needs, but also provide surgeons with a solution that was not available to them before. UNiD IB3D Patient-Matched interbody cages allow the surgeon to accommodate geometrical inconsistencies (such as an asymmetric anatomy) of endplates and vertebral bodies, thus improving surgical and clinical outcomes.
 
UNiD IB3D Patient-Matched interbody cages designed through the UNiD ASI pre-operative surgical planning tool provide surgeons with accurate patient-specific implantable devices and help streamlining implant inventory in the operating room.
 
Denys Sournac, CEO 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. 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.”
 
Earlier this month, MEDICREA reached more than 5,000 cases with its proprietary UNiD ASI technology platform and using patient-specific implants manufactured by the company. MEDICREA designed UNiD ASI to assist surgeons’ pre-operative case planning and execution of patientspecific surgical strategies. To do so, UNiD LAB biomedical engineers create patient-specific surgical plans, which manifest in the creation of patient-specific implants after surgeon’s approval. Next, MEDICREA collects and analyzes post-operative data on an ongoing basis to continuously improve its technology.