A 3D-printed device developed by Curiteva incorporating PEEK filament from Evonik was surgically implanted last week in Allentown, PA. It’s the first time a 3D-printed interconnected porous PEEK structure made with VestaKeep i4 3DF filament has been implanted in the United States, according to Evonik. The 3D-printed implant received 510(k) clearance from FDA in February 2023, the first such device cleared by the agency for commercial use.
Privately held Curiteva was founded in 2017 in Huntsville, AL, by a machinist entrepreneur dedicated to developing a portfolio of spinal implants and, notably, 3D-printed porous PEEK implants. The implant used in the surgery came from the company’s Inspire line of devices. That platform is manufactured using VestaKeep i4 3DF PEEK filament on a proprietary printer designed, programmed, and built by Curiteva.
According to Alex Vaccaro, MD, PhD, president of Philadelphia-based Rothman Orthopedic Institute, the lattice PEEK architecture enabled by Curiteva’s 3D-printing process “represents an exciting advancement in spine, orthopedics, and neurosurgical procedures which involve any type of biologic implant."
The Inspire porous PEEK technology checks all of the boxes for an ideal interbody implant, added Kevin Foley, MD, chairman of Semmes-Murphey Neurologic and Spine Institute and professor of neurosurgery, orthopedic surgery, and biomedical engineering at the University of Tennessee Health Science Center. He cited its “fully interconnected porosity, modulus of elasticity equivalent to cancellous bone, strong biomechanical properties, radiolucency, and a bioactive surface for osseointegration.”
VestaKeep i4 3DF comes in filament form and meets the stringent requirements of ASTM F2026, which is the standard for PEEK polymers approved for use in surgical implant applications, said Evonik. It is the world’s first 3D-printable filament to meet this requirement for medical use, according to the Essen, Germany–based specialty chemicals company.
In addition to implant-grade filaments, Evonik produces a testing-grade PEEK filament that offers the same properties without the documentation needed for surgical implants. Its other 3D printing materials are used in highly demanding environments, and include resins suitable for photocuring and powders designed for sintering-based manufacturing processes.