Huntsville, AL primarily based know-how producer Curiteva introduced FDA 510(ok) clearance of the Encourage 3D Printed Trabecular PEEK Lumbar Interbody Fusion System to be used in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. This marks the corporate’s second FDA cleared 3D printed PEEK implant with HAFUSE, following the approval of the Encourage Trabecular PEEK Cervical Interbody Fusion System in February 2023. The Encourage Cervical implant represented the trade’s first 3D printed PEEK machine to obtain regulatory clearance with over 1,000 profitable implantations in additional than 500 sufferers because the April 2023 launch. The corporate plans a business introduction of Encourage for TLIF and PLIF procedures in Q2 of this yr.
The Encourage platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and constructed by Curiteva. Founder and Chairman, Chad Falciani emphasised, “Along with our proprietary printing operation, we now have assembled an FDA Grasp File and carried out rigorous high quality and course of controls which demonstrates the method efficiency is extraordinarily succesful.”
This ground-breaking additive course of produces a totally interconnected and built-in trabecular PEEK lattice construction traversing your complete implant to advertise osseointegration, enhance radiographic evaluation, and ship superior biomechanics. The primary-to-market mixture of the HAFUSE nanotechnology floor remedy and novel trabecular PEEK construction creates a hydrophilic, bioactive setting for cell attachment, proliferation, and therapeutic in pre-clinical animal and in vitro research.
“Developments in PEEK during the last decade have been cost-prohibitive and operationally difficult to scale. Our expertise and dedication to lean operational effectivity allowed us to speed up our proprietary print operation leading to over 7,000 implants now commercially obtainable in stock,” added Falciani.
“Reported affected person outcomes for Encourage cervical within the first 9 months reinforce our pre-clinical observations and we plan to publish these outcomes later this yr. Our work continues in earnest to develop extra spine portfolio merchandise leveraging this proprietary know-how. We’re grateful for our companions at MCRA, Empirical, Promimic, and Evonik for his or her extraordinary assist on this regulatory path we’re forging to advance additive PEEK manufacturing to enhance affected person therapeutic and outcomes within the spine and MSK area,” commented, CEO Mike English.
Curiteva is a privately held know-how and manufacturing firm primarily based in Huntsville, AL. Our enterprise is based on a dedication to constructing world-class manufacturing, accelerating analysis and improvement, sustaining lean operational self-discipline, and delivering novel know-how to fulfill the evolving wants of our clients and the sufferers they serve. Curiteva is pioneering 3D printing of Trabecular PEEK implants with a bioactive nano-surface to revolutionize how engineered buildings and implant biomaterials speed up immunomodulation, improve therapeutic, and enhance affected person outcomes. For extra data, please go to www.curiteva.com