the EVOS System and FDA 510(k) Clearance
Cutting Edge Spine, a technology driven developer and marketer of highly differentiated implant systems, announced that the US Food and Drug Administration has cleared the EVOS-ha, a groundbreaking lumbar interbody system that combines two proven biomaterials, PEEK-OPTIMA® and Hydroxyapatite, to enhanced fusion.
“With the approval of the EVOS system, offered in both PEEK-OPTIMA® Natural and PEEK-OPTIMA HA® Enhanced (i.e. Hydroxyapatite), we are proud to be the first-to-market in the US lumbar spine space with the HA enhanced option,” said Randy Roof, President. He added, “Our strategic partnership with the Invibio™ Biomaterial Solutions (“Invibio”), was key to successful technology development and approval by the FDA. We look forward to the positive impact the EVOS will have on fusion rates, and ultimately, patient care.”
The innovative PEEK-OPTIMA® HA Enhanced, offered by Invibio™ Biomaterial Solutions (“Invibio”), has similar mechanical properties to PEEK-OPTIMA® Natural and a modulus similar to that of cortical bone. The introduction of HA, which is fully integrated into the PEEK-OPTIMA® Natural grade, provides a complete homogeneous compound that ensures HA is present at all surfaces of a device. Like PEEK-OPTIMA® Natural, PEEK-OPTIMA HA® Enhanced is radiolucent, allowing visualization of the fusion mass, and has proved to be fully biocompatible.
“Our goal is to provide today’s market with tomorrow’s technology,” said John Souza, Director of Research and Development at Cutting Edge Spine. He added, “to that effect, we have also made the decision to maximize safety by having all EVOS implants packaged in a single use, bar coded, and pre-sterilized blister.” He added, “We also provide surgeons with over 2,500 footprints to choose from, allowing physicians to precisely adapt the EVOS system to their clinical requirements.” The combination of a cutting edge design, a novel material, 2,500 footprints, and sterile packaging makes the EVOS an industry game-changer and the solution of choice for lumbar interbody fusion. Cutting Edge Spine is currently in the process of commercializing the new technology and establishing distribution throughout the United States.