Europeanhhm

Curiteva Introduces World's First 3D Printed PEEK Device with Regulatory Clearance for Full Commercial Launch in the United States

Wednesday, July 19, 2023

Curiteva, a privately held technology and manufacturing company based in Huntsville, AL, proudly announces the full commercial launch of its innovative Inspire Porous PEEK HAFUSE Cervical Interbody System. This groundbreaking 3D printed interbody fusion device received regulatory clearance earlier this year, making it the world's first fully interconnected porous PEEK implant with optimal characteristics for bony healing.

The limited release in April received positive feedback from surgeons, contributing to the excitement surrounding the full commercial launch. Mark Mohlman, EVP at Curiteva, expressed enthusiasm about the product's adoption and the company's plans to expand its lumbar portfolio with a scheduled launch in 2024.

The Inspire platform is manufactured using Curiteva's proprietary, patented Fused Filament Fabrication 3D printer, resulting in a fully interconnected porous structure that promotes osseointegration, enhances radiographic assessment, and provides superior biomechanics. The combination of the HAFUSE nanotechnology surface treatment and the novel porous PEEK structure creates a hydrophilic, bioactive environment that fosters cell attachment, proliferation, and healing, as demonstrated in pre-clinical animal and in vitro studies.

CEO Mike English commended the Curiteva team for achieving this milestone and expressed gratitude to surgeons and distributors for their support. The successful FDA clearance in February and the subsequent alpha release in April paved the way for the Inspire Porous PEEK HAFUSE Cervical Interbody System's full commercial launch in July, marking a significant advancement in medical technology.

https://curiteva.com/curiteva-announces-worlds-first-3d-printed-peek-device-with-regulatory-clearance-reaches-full-commercial-launch-in-the-united-states/

Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital CongressHealthcare Innovation & Transformation SummitHealthcare CNO SummitHealthcare CMO SummitThe Healthcare Patient Experience & Engagement Summit 2024