Medicrea scored an FDA OK for its 3D-printed titanium interbody devices for spine surgery.
The IB3D suite of devices features the company’s surgeon-adaptive technology, dubbed AdapTEK, which allows surgeons to design interbody devices according to individual specifications, the company said in a statement. Medicrea then creates the implants at its in-house additive manufacturing facilities.
With the technology, surgeons are able to customize footprints, lordotic angles, heights, lateral windows and endplate surface structure, Medicrea said.
“With the FDA clearance of our 3D-printed Titanium interbodies, we are able to approach a large segment of the spine market, where we were not previously present, with an adaptive range of implants delivered according to the clinical preferences and practices of individual spine surgeons,” said Denys Sournac, Medicrea CEO, in the statement.
This will pave the way for future FDA clearances, which will allow the company to combine the IB3D line with its UNiD Adaptive Spine Intelligence platform, Sournac said.
Medicrea picked up $22.4 million in August 2016, which it pegged for the U.S. and international commercialization of its UNiD Patient-Specific Rods. FDA-cleared in 2014, the devices are customizable to each patient’s spinal alignment, which helps reduce the risk of spinal implant failure.