Emerging Implant Technologies cervical cage
EIT Cellular Titanium Cervical Cage
Emerging Implant Technologies GmbH (EIT) has received clearance from the U.S. Food and Drug Administration (FDA) for the expansion of the label of their 3D printed EIT Cellular Titanium Cervical Cage.
EIT Cellular Titanium is a porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimise cell proliferation and bone ingrowth. It has been designed for use in multiple contiguous cervical levels in the upper body (C2 to T1). The anatomical design of the EIT cervical cage assists the surgical and biomechanical challenges of cervical multi-level fusion by adapted to maximised vertebral endplate contact and sagittal balance restoration.
The fusion potential of the implants is supported by EIT’s proprietary 3D process including post-printing etching procedures, allowing for unique porous structures that are impossible to manufacture with traditional manufacturing techniques. Founded in 2014, it has been EIT’s mission to bring spinal implants, designed according to the latest science on optimal bone ingrowth in porous titanium scaffolds and manufactured with 3D printing techniques, to market.
“This is another important regulatory milestone for EIT,” said Guntmar Eisen, Founder and CEO of EIT. “Only very few cervical cages are approved for multilevel use and we are poised to quickly enter the U.S. market with the most advanced technology and state of the art FDA labeling and compliance.”
Thought to be the first multi-level 3D printed cervical cage to enter the U.S. market, the EIT cervical cage is to be used with supplemental fixation and designed for use with autogenous and/or allogenic bone graft to facilitate fusion. Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), assisted EIT on the FDA strategy and submission.
Justin Eggleton, Senior Director of Regulatory Affairs commented: “This clearance represents continued synergy between FDA and the medical community. The expanded indications to multiple levels in the cervical spine facilitates improved surgeon collaboration and the ability to collect data that will strengthen the total product lifecycle, which ultimately benefits patients.”
