Additive Manufacturing Strategies

Emerging Implant Technologies Receives New FDA Clearance for 3D Printed Implants

ST Medical Devices

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There are several companies out there specializing in the treatment of spinal conditions using 3D printed implants, but one that stands out is Emerging Implant Technologies (EIT), a German company that holds the distinction of being the first medical device manufacturer in the orthopedic field to exclusively focus on implants made using additive manufacturing. EIT’s specialty is its Cellular Titanium technology, a porous titanium material whose structure is close to that of cortical and cancellous bone. Its design facilitates the regrowth and incorporation of natural bone, and has made a major impact on the medical field and on the patients who have benefited from treatment with the implants.

Celluluar Titanium spinal implants were given FDA clearance last year, and now EIT has received FDA clearance again, this time for the expansion of their EIT Cellular Titanium Cervical Cage to be used in multiple contiguous cervical levels (C2 to T1). The design of the cervical cage assists the surgical and biomechanical challenges of cervical multi-level fusion by adapting to maximized vertebral endplate contact and sagittal balance restoration. 

The implants’ fusion potential is supported by EIT’s proprietary 3D printing process, which includes post-printing etching procedures and allows for unique porous structures that cannot be manufactured with traditional manufacturing techniques.

“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 US market with the most advanced technology and state of the art FDA labeling and compliance.”

The EIT Cellular Titanium Cervical Cage is the first multi-level 3D printed cervical cage to enter the US market. It is designed to be used with autogenous and/or allogenic bone grafts to facilitate fusion, and should be used with supplemental fixation.

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) assisted EIT on its FDA strategy and submission.

EIT Cellular Titanium

“This clearance represents continued synergy between FDA and the medical community,” said Justin Eggleton, Senior Director of Regulatory Affairs. “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.”

Spinal conditions have always been difficult to treat, which is why technology like that offered by EIT is so exciting. The company’s Cellular Titanium implants not only replace but help to regrow bone, leading to faster and more complete healing. EIT has plenty more innovations coming to the market before long, too. In the second quarter of this year, the company plans to add to its product portfolio with a lateral lumbar cage in the second quarter of 2018 and a fully 3D printed lateral expanding cage in the fourth quarter.

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts below.

[Images: EIT]

 

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