Cutting Edge Spine Receives FDA 510(k) Clearance for EVOS System

The U.S. Food and Drug Administration (FDA) has cleared Cutting Edge Spine’s EVOS system, an array of interbody implants manufactured in PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced, both offered by Invibio Biomaterial Solutions.

“With the approval of the EVOS system, we are proud to be first-to-market in the U.S. with an HA enhanced PEEK Lumbar Interbody system,” said Randy Roof, Cutting Edge president and co-founder. “Invibio´s PEEK-OPTIMA HA Enhanced has been compounded with hydroxyapatite (HA), an osteoconductive material, to enhance bone apposition.The integration of two proven Invibio biomaterials combined with cutting-edge designs and the largest range of footprints in the market is truly a game changer. Our partnership with Invibio made it possible, and was key to obtaining FDA clearance. We look forward to the impact that the EVOS system will have on fusion rates, and ultimately, patient care.”

PEEK-OPTIMA HA Enhanced shares all of the material properties that originally made PEEK-OPTIMA Natural the leading material for spinal interbody fusion devices, including a modulus similar to that of cortical bone and radiolucency, allowing visualization of the fusion mass, according to a Cutting Edge Spine news release. Hydroxyapatite is fully integrated into the PEEK-OPTIMA Natural Grade, providing a complete homogeneous compound that ensures HA is present on all surfaces of a device.

“Supporting Cutting Edge Spine in every phase of the development of the new EVOS system now entering the U.S. market allowed us to contribute to a solution that we believe will have positive impact on the quality of life of patients with clinical conditions,” said John Devine, Ph.D., director of Invibio Biomaterial Solutions.

Invibio´s PEEK-OPTIMA HA Enhanced polymer has demonstrated its performance in pre-clinical studies, with superior new bone formation and quality of new bone bridging compared with PEEK-OPTIMA Natural at early time points.¹ A further study that evaluated the bone on-growth of the two implantable polymers in a bone defect model in sheep revealed that PEEK-OPTIMA HA Enhanced resulted in approximately 75 percent direct bone apposition as early as four weeks following implantation.²

“Our goal is to provide today’s market with tomorrow’s technology,” said John Souza Sr., director of Research and Development at Cutting Edge Spine. “To that effect, we have taken a no-excuse approach, providing surgeons with 3,714 lumbar implant options, and hospitals with single use, bar coded, and pre-sterilized packaging.”

Cutting Edge Spine currently is in the process of commercializing the new technology and establishing distribution throughout the United States.

Founded in 2009, Cutting Edge Spine (CES) develops and distributes spinal technologies. The privately owned company is headquartered in Waxhaw, N.C.

References:

1. Study evaluated the in-vivo response in a cervical spine fusion model in sheep. Study did not use Cutting Edge Spine products. Data on file at Invibio. This has not been correlated with human clinical experience.

2. Study evaluated bone ongrowth in a bone defect model in sheep. Study did not use Cutting Edge Spine products. Data on file at Invibio. This has not been correlated with human clinical experience.