Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the FDA has granted clearance of the first 3D-Printed PEEK Interbody System made from PEEK-OPTIMA.
Nvision Biomedical Technologies
The 3D-Printed PEEK Interbody System from Nvision Biomedical Technologies was co-developed with Invibio Biomaterial Solutions. The system consists of Cervical and Anterior Lumbar Interbody Fusion (ALIF) spine devices, each incorporating extensive porous structures that have the potential to promote multi-directional bone ingrowth and improve device fixation, whilst also maintaining PEEK-OPTIMA’s inherent benefits in modulus and imaging.
The use of PEEK-OPTIMA - a material that has already been used in over 15 million implants - offers the benefits of mechanical properties closer to those of bone and also superior imaging capability than titanium implants, the latter allowing surgeons to more accurately monitor fusion progression. Nvision’s 3D-Printed PEEK Interbody System is a standout in the field of spinal devices as it is the first to combine PEEK-OPTIMA with the design freedom enabled by the Bond3D additive manufacturing technology to print solid and porous areas for bone ingrowth.