Medicrea’s Patient-matched Interbody Cages FDA Approved
Medicrea has announced FDA clearance for their UNiD® IB3D Patient-Matched interbody cages which will be added to their UNiD® Adaptive Spine Intelligence (ASI) platform.
The 3D-printed titanium implant is the first of its kind to offer such a wide range of customizability in regards to cage dimensions and endplate morphology.
The cages are designed using the UNiD® ASI pre-operative surgical planning tool to match the patient’s optimal anatomical requirements and take into account every patient’s unique endplates and vertebral bodies differences.
In a press release following the FDA clearance, Medicrea founder and CEO, Denys Sournac, states:
“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. “
Spinal Implants & VCF Market
One of the key drivers for the interbody device market is the increase in the target population, which is composed of ageing baby boomers. The majority of spinal fusion procedures are performed on those individuals over the age of 60. This age group is the fastest-growing demographic in the United States.
Minimally invasive interbody options will continue to cannibalize areas of the standard interbody market, particularly traditional anterior lumbar interbody fusion (ALIF) and posterior interbody fusion (PLIF) approaches. The U.S. spinal implant and vertebral compression fracture (VCF) market is expected to increase at a CAGR of 1.0% to reach $6.5 billion by 2025.
To get in an in-depth global market analysis including interviews, procedural volumes, and forecasts, refer to iData Research’s report suites: