Curiteva Releases 3D Printed PEEK Device in the United States

Curiteva has commercially launched its Inspire Porous PEEK HAFUSE Cervical Interbody System in the United States. 
 
The company pioneered and received U.S. Food and Drug Administration (FDA) clearance earlier this year for the first 3D printed, fully interconnected porous PEEK interbody. This advancement in additive manufacturing of polymers creates a new classification of interbody fusion devices with optimal characteristics for bony healing.
 
“We are very pleased with the positive surgeon feedback we received during our limited release in April. Now with full commercialization, the team is excited to see continued adoption of our novel 3D printed porous PEEK implant with HAFUSE Technology,” Curiteva Executive Vice President Mark Mohlman stated. “This launch is just the beginning as we continue to develop our additional lumbar portfolio scheduled for launch in 2024.”
 
The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and built by Curiteva. This additive process produces a fully interconnected and integrated porous structure traversing the entire implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics. The first-to-market combination of the HAFUSE nanotechnology surface treatment and novel porous PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.
 
“Curiteva received FDA clearance in February, initiated our alpha release in April and scaled to a commercial launch in July. I am proud of the entire Curiteva team for another milestone achievement, and grateful to our surgeons and distributors for their patience and support,” Curiteva CEO Mike English said. 
 
The Inspire technology will be featured at the North American Spine Society meeting later this year. 
 
Based in Huntsville, Ala., Curiteva is a privately held technology and manufacturing company that advances spine surgery and improves clinical outcomes by partnering with providers and suppliers to deliver implant systems to the market.