Vertera Spine Announces First Implantations of Porous PEEK COHERE Cervical Fusion Device

ATLANTA, June 6, 2016 /PRNewswire/ -- Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the first wave of implantations with the COHERE™ Cervical Interbody Fusion System. COHERE is Vertera Spine's first device featuring the company's patented porous PEEK (polyetherether ketone) Scoria™ biomaterial technology. While porous metal or metal-coated implants have found their way into spinal fusion applications, COHERE is the first device in clinical use to be manufactured entirely out of PEEK and contain porosity.

Intended for use in anterior cervical fusion procedures to treat complex, single or multi-level spinal pathologies, COHERE combines the benefits of introducing a porous osteoconductive environment to bone without compromising the mechanical integrity of the implant.¹ Multiple studies in the literature report the advantages of adding porosity over two-dimensional roughness to implants to improve their ability to osseointegrate.² PEEK Scoria's three-dimensional porous structure has been specifically tailored to optimize bone formation on the cellular level as well as effectively form a strong interface with bone. Since the implant is made entirely out of PEEK polymer, COHERE also provides the additional advantage of not producing any medical imaging artifacts, allowing accurate visualization of the fusion site when compared to metallic implants.

To date, COHERE has been implanted at a select number of premier orthopaedic and spine surgical sites, including Rush University in Chicago, Ill. Frank Phillips MD, Professor at Rush University was one of the first surgeons to use COHERE in a cervical fusion surgery. Dr. Phillips will be presenting new data on the PEEK Scoria technology at the upcoming State of Spine Surgery Annual Symposium on June 30-July 2 in Los Cabos, Mexico.

"I think the porosity of the COHERE PEEK interbody device will allow for more rapid osseointegration seen with textured surface devices, while at the same time allowing for excellent radiographic visualization of the fusion," said Dr. Phillips. "From the substantial research compiled, we have learned that Scoria's porosity promotes implant osseointegration with the surface characteristics being more important than the implant material."

While competitive PEEK fusion devices are treated with metal coatings that can delaminate during and after surgery, porous PEEK Scoria is grown directly from the solid PEEK implant through a patented processing method, exhibiting twice the shear strength of vertebral trabecular bone.¹

"Using the COHERE implant was a seamless transition from the allograft cage I previously used. I have been impressed with its easy insertion as well as the durability of the porous PEEK during implantation," said Richard Fessler MD, also professor at Rush University.

Several of the first surgeries have also been performed in the state of Georgia, near Vertera Spine's headquarters in Atlanta. James L. Chappuis MD, FACS, CEO, and chief surgeon at SpineCenterAtlanta in Atlanta, Ga., has implanted over a dozen COHERE implants to date.

"I have been looking forward to adopting COHERE into my clinical practice. Vertera Spine's porous PEEK Scoria addresses the challenges of current PEEK cages that are bioinert as well as metal cages that make it difficult to assess fusion on X-ray and CT," said Dr. Chappius.

Likewise, J. Kenneth Burkus MD, another COHERE clinical user from the Hughston Clinic in Columbus, Ga. shares similar sentiments.

"The ability of COHERE to osseointegrate and not produce any imaging artifacts is unprecedented for spine fusion devices. What convinced me to use this device is the fact that the porous PEEK implant is made from one material and does not have to rely on any coatings to provide osteoconductivity," said Dr. Burkus.

"The first clinical use of porous PEEK represents a significant milestone for Vertera Spine and can be contributed to the hard work and ingenuity of our entire team," said Chris Lee PhD, president and CEO of Vertera Spine. "The adoption of COHERE by this initial group of key opinion leaders, along with research support from leading academic institutions, speaks volumes about the impact that COHERE and other implants made with our multifunctional PEEK Scoria biomaterial can have on the spinal fusion market."

COHERE is available in multiple footprints and heights with a 7° lordotic angle. Vertera Spine is planning a full market release of COHERE in the coming months.

About Vertera Spine:

Vertera Spine is a privately-held medical device company working to develop and commercialize a portfolio of surgical solutions that use or complement its patented porous technology to address critical clinical needs in spine procedures. The company has received funding from the National Science Foundation, Georgia Research Alliance, and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.com or call 678.705.9039.

COHERE and Scoria are trademarks of Vertera Spine. All other trademarks and trade names are the property of their respective holders.

¹ Evans NT, et al. Acta Biomaterialia, 2015; 13: 159-167.
² Walsh WR, et al. The Spine Journal, 2015; 15(5): 1041-1049.

SOURCE Vertera Spine

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http://www.verteraspine.com