Spinal interbody fusion devices have traditionally been classified by the implant material, either synthetic or tissue-derived alternative (e.g. autograft and allograft). However, as more advanced orthopedic biomaterials are developed, the use of a single coding identifier for all synthetic devices may no longer be appropriate for accurately describing fusion procedures. Five years of basic science, preclinical and clinical research1-3 have shown that porous PEEK possesses several performance characteristics that distinguish it from other fusion devices by combining the osseointegration capabilities of porous metallic devices with the favorable imaging properties of non-porous plastic devices. This valuable combination of device attributes was introduced with FDA clearance of the COHERE device, prompting the issuance of the new ICD-10 code by CMS.
In addition to serving as a tracking method for healthcare payers and providers, the ICD-10 code can also potentially benefit spine surgeons in clearly identifying the best options for patients.
"The issuance of this new code signifies the unique performance of porous PEEK devices compared with other fusion devices and the importance of monitoring how this technology impacts healthcare," said Richard Guyer, M.D., Texas Back Institute. "As a clinician, I am always looking for innovative technologies, such as Vertera Spine's porous PEEK COHERE device, that have the potential to improve patient outcomes."
As stated by Kevin Foley, M.D., Semmes-Murphey Neurologic and Spine Institute:
"The development of porous PEEK has allowed for the combination of radiolucency and porosity in an interbody implant that is completely plastic. In vivo studies have demonstrated that bone will grow into porous implants, improving their osseointegration. Until now, the only porous implants clinically available were made of metal or had a metallic coating, which can limit the surgeon's ability to assess fusion on imaging. This new code gives us the potential to better correlate bony tissue ingrowth into Vertera Spine's porous PEEK COHERE device with clinical outcomes."
Likewise, Erik Westerlund, M.D., St. Francis Spine Center, and an early adopter of Vertera Spine's COHERE device, shared similar sentiments:
"I began to see my one year follow-up COHERE device patients in May of this year and the results have shown a clear and consistent trend of rapid and readily visible progression to robust osseous union. Not only is there characteristic radiographically visible osseous incorporation at the interconnected porous margin of the COHERE PEEK spacers, there is also a notable continuity of bridging bone across the entire interspace. The grant of a new specific ICD-10 code for porous PEEK will provide myself and other spine surgeons greatly refined capacity to track clinical outcomes and cost savings with this genuinely transformational class of porous PEEK interbody spacers like Vertera Spine's COHERE."
With its first clinical use in Q2 of 2016, COHERE is the first device featuring Vertera Spine's patented porous PEEK biomaterial technology. Intended for use in anterior cervical fusion surgery, COHERE contains a three-dimensional porous architecture on its bone-contacting sides that is specifically designed and optimized to promote cellular bone formation and effectively form a strong interface with bone. Unlike some porous treatments that are coated onto the device, COHERE's porous architecture is grown directly from the solid PEEK implant using a proprietary processing method that allows for bone tissue ingrowth on the surface, while retaining strength and durability.
"We are excited that CMS has adopted a new code for radiolucent porous devices and are pleased that COHERE will fall under this designation," said Chris Lee. Ph.D., founder and CEO of Vertera Spine. "The availability of a radiolucent porous fusion device means that for the first time, bone tissue ingrowth can potentially be assessed into the device. This will allow us to further understand the role of implant integration with clinical outcomes."
1Smith KE, et al. Techniques in Orthopaedics, 2017 (accepted in press).
2Torstrick FB, et al. CORR, 2016; 474(11): 2373-2383.
3Evans NT, et al. Acta Biomaterialia, 2015; 13: 159-167.