3D Printed Spinal Devices Approved by FDA

No longer are 3D printed medical implants a thing of science fiction, as our readers know. Now, two companies, Nvision Biomedical Technologies and Invibio Biomaterial Solutions, have co-developed the first 3D printed PEEK Interbody System, consisting of devices for spinal infusions. Specifically, they created Cervical and Anterior Lumbar Interbody Fusion (ALIF) spine devices using PEEK-OPTIMA™. Last week, they announced that the U.S. Food and Drug Administration (FDA) granted clearance for their interbody system, so it will now be available for clinical use.

PEEK, or polyether ether ketone, is a semi-crystalline thermoplastic often used for medical applications because it is sterilizable, biocompatible, and heat, wear, and chemical resistant. PEEK has properties similar to bone, meaning, if implanted, it can promote the reconstruction of tissues around the implant, accelerating osseointegration. PEEK-OPTIMA has already been used in over 15 million implants, and its superior imaging capability also allows surgeons to accurately monitor fusion progression.

This close-up of the Nvision Interbody System shows its porous PEEK-OPTIMA structure (photo credits: Invibio)

Nvision and Invibio’s ALIF spine devices each incorporate porous and solid structures. John Devine, MD of Invibio, defined their purpose, explaining that “The combination of solid and highly intricate porous PEEK-OPTIMA structures within the Nvision system allows for potential bone ingrowth to achieve fixation while maintaining the inherent benefits of PEEK-OPTIMA for imaging and bone-like modulus.”