The Food and Drug Administration has just cleared a hydroxyapatite (HA) porous PEEK interbody cervical implant for spine fusion, which is manufactured by Salt Lake City based Innovasis, Incorporated.
The device’s trade name is HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System. According to the FDA’s clearance document, the HAcancellous PEEK-C device is “indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-Tl. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.”
Additionally, the device is to be “used in patients who have had six weeks of non-operative treatment. The HAcancellous PEEK-C device is to be used with supplemental fixation, such as the lnnovasis Oryx® Cervical Plate System. The HAcancellous PEEK-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.”
The FDA found the device substantially equivalent to the Innovasis CxHA® PEEK Cervical IBF System and the NuVasive, Inc. Cohere Cervical IBF. According to the Innovasis press release, the HAcancellous PEEK-C Implant may “provide an increased opportunity for bone ingrowth and for achieving early integration.”
In the press release, Innovasis Director of Marketing and Education Russ Whetton said, “We are very excited for this next evolution in interbody fusion devices. To be able to construct an implant similar to cancellous bone is a major achievement.”
Whetton continued, “We are seeing amazing results from our current Bioactive implants with fusion rates and patient satisfaction. Being able to add the next evolution of Bioactive implants to our BioBase® registry is very exciting!”
According to Innovasis, the BioBase registry is a “multicenter, observational, quality-assessment repository.” The registry enables surgeons to gather patient outcomes and fusion data in a “secure, HIPAA-compliant database that is accessed on a real time basis.”
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