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October 6, 2015

FDA grants 510(k) clearance for Vertera’s new Cohere cervical interbody fusion device

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Vertera Spine's Cohere cervical interbody fusion device.

Vertera

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Vertera Spine’s Cohere cervical interbody fusion device.

The device features the company’s new Peek Scoria biomaterial, a porous surface technology based on Zeniva Peek resin from Solvay Specialty Polymers.

Developed in collaboration with a select team of surgeons, the device uses Peek Scoria to combine the benefits of introducing a porous environment to bone without compromising the implant’s mechanical integrityt.

The device also provides the additional advantage of not producing any medical imaging artifacts, allowing surgeons to easily assess the fusion site.

The company will launch the Cohere device in multiple footprint and height configurations in 2016.

Vertera Spine co-founder and CEO Dr Chris Lee said: "The FDA clearance of Cohere represents a significant milestone for Vertera Spine and fusion devices in spine.

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"Given the new economics of healthcare, market demands are shifting towards more effective implant technologies at a better price.

"Surgeons have been seeking an all Peek fusion solution that leads to direct bone apposition instead of fibrous encapsulation."

"Cohere, featuring surface porous Peek Scoria, will be the first in a new generation of biomedical implant innovations to meet this demand."

The cost-effective Peek Scoria was developed to meet the clinical need of fusion devices, allowing improvement of osseointegrate and facilitating bone tissue in-growth.

Peek Scoria features a fully interconnected pore network with 300µm average pore size, over 500µm layer thickness, and wettable surface.

Vertera Spine spine and orthopedics industries board director Tim Nash said: "Surgeons have been seeking an all Peek fusion solution that leads to direct bone apposition instead of fibrous encapsulation.

"Cohere is a game-changing device for spine fusion. By leveraging the performance of the Scoria technology, Vertera Spine will be able to generate a portfolio of implant solutions that were previously not possible."


Image: Vertera gets FDA clearance of first surface porous Peek interbody fusion device. Photo: courtesy of PRNewswire/Vertera Spine.

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