FDA 510(K) Clearance of its New HA Enhanced PEEK Interbody for the Cervical Spine, the EVOL ha-C
Cutting Edge Spine, a US leader in the development and commercialization of bio-active technologies for the spine, today announced the 510(k) clearance and commercial launch of it’s latest innovation, the EVOL® ha-C cervical interbody system.
The EVOL® ha-C system is made of PEEK-OPTIMA™ HA Enhanced material supplied by Invibio™ Biomaterial Solutions. Cutting Edge Spine implants made from the material have demonstrated early onset bone formation and apposition to it’s implants; as presented at NASS 2016, NASS 2017, Selby Spine Society 2017, and Becker’s Spine Symposium. The EVOL® ha-C system leverages Cutting Edge Spine’s acuity relative to developing systems made from the material in order to offer superior inter-body options to Surgeons looking for superior and early onset new bone formation and bony apposition to the implant during the fusion process.
“The EVOL® ha-C cervical inter-body system demonstrates the strong confidence we have in our ability to deliver improved clinical outcomes,” said Randy Roof, President and Co-Founder. “The EVOL® ha-C cervical system is our second HA Enhanced PEEK-OPTIMA™ system to be 510(K) cleared this year; and with an ALIF, DLIF and OLIF system forthcoming in 2018 Cutting Edge Spine, arguably, will be offering the world’s largest Bio-Active interbody portfolio.”
“The EVOL® ha-C system combines Invibio’s leadership in PEEK and Cutting Edge Spine’s second to none clinical experience and engineering expertise in HA enhanced PEEK Interbodies,” said Kyle Kuntz, manager of Research & Development at Cutting Edge Spine. “Our growing and compelling body of work demonstrates improved outcomes with HA enhanced PEEK. We are proud to have the opportunity to make it available to patients and surgeons.”
Cutting Edge Spine is currently in the process of launching the technology nationwide. The leadership team will be attending NASS in Los Angeles, September 26-29, 2018 and looks forward to meeting anyone looking to make a difference.
1) Comparative Study Finds Performance Advantages with PEEK-OPTIMA™ HA Enhanced Polymer