FDA Cleared Orthopedic Spine

Medicrea wins FDA clearance for patient-matched spinal interbody cages

Medicrea (EPA:ALMED) announced today that it won FDA clearance for its UNiD IB3D patient-matched interbody cages to complete its UNiD adaptive spine intelligence (ASI) platform technology.

The UNiD IB3D interbody cages are 3D-printed titanium implants designed to customize cage dimensions, features and endplate morphology. Medicrea touts this level of customization as the first of its kind to become commercially available on the spinal device market.

Lyon, France–based Medicrea’s device is designed to match the patient’s surgical and anatomical requirements by mapping out the anatomy of each vertebrae endplate through the 3D reconstruction of the spine. The cage is designed to restore the proper height and angulation and offer an optimized surface contact between the implant and the endplates, improving the stability of the segment and reducing subsidence.

The UNiD IB3D cages are designed through the UNiD ASI pre-operative surgical planning tool, which is designed to offer surgeons accurate, patient-specific implantable devices to streamline inventory in the operating room. Last month, Medicrea landed seven new patents for the UNiD ASI platform.

Medicrea founder & CEO Denys Sournac said in a news release that, before today, the only FDA-cleared patient-matched implants came in the form of cranioplasty implants, which are “mainly aesthetic and do not bear any weight.” Medicrea’s product will be the first for load-bearing applications specifically for spine surgery, the executive added.

“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,” Sournac said.

Original Article: (https://www.massdevice.com/medicrea-wins-fda-clearance-for-patient-matched-spinal-interbody-cages/)

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