Weigao and Invibio Join Forces on Spine Device in China

Weigao Orthopaedic Device Co. Ltd., Chinese manufacturer of implants and related surgical instruments for traumatology and spine surgery, now is offering the spinal stabilization system Tulip, which uses semi-rigid rods made from PEEK-Optima to bridge the gap between rigid and dynamic systems. The system is indicated when one to three levels of the spine, including the lumbosacral region, require posterior pedicle-screw fixation or when fusion surgery is required for a segment of the spine where degenerative disc disease is present.

PEEK-Optima is a high-performance, implant-grade polymer made by Invibio Inc., a West Conshohocken, Pa.-based biomaterials company. Invibio also has offices in Beijing, China.

“Throughout the product development and clinical adoption of our PEEK-Optima semi-rigid rods, Invibio was a great help to our company,” said Kui Yang, vice general manager of sales at Weigao Orthopaedic Device Co. “This includes technical support and testing during the [research and development] phase. Invibio invited, for example, overseas clinical experts to China to exchange experience in PEEK-Optima based semi-rigid-rod techniques. In addition multi-center program discussions assisted in launching the product and promoting its clinical adoption. We appreciate the value of our relationship with Invibio, and we hope to continue our collaboration.”

Two types of the domestic manufactured rods are available: a 6.35 millimeter (mm)-diameter round rod, and a 6.35 x 7.2 mm-diameter oval rod. Following previous China Food and Drug Administration approval of other PEEK-Optima-based products, the Tulip system received its approval in 2014 and targets China’s tier-one market for spinal devices as well as class two and class three (top level) hospitals nationally.

PEEK-Optima polymer-based spinal rod components are touted to bridge the treatment gap between rigid and dynamic systems. According to research results presented in Europe the rods are strong enough to restore lumbar spine stability and have much lower failure rates than titanium. Spinal rods made from the biocompatible polymer are meant to improve load sharing to encourage fusion, offer more physiologic loading at adjacent levels, which may decelerate degeneration, and reduce stress at the bone-to-screw interface, which may prevent screw pull-out, especially in patients with questionable bone quality. This improved load sharing, plus clear, artefact-free imaging for easy device placement and monitoring, are important advantages that PEEK-Optima provides over metal rods, according to Invibio.

Being non-metallic, PEEK-Optima does not produce metal ions when implanted, and offers high strength combined with a modulus very similar to that of human bone. The implantable material has a 15-year history of successful clinical application, Invibio reports, and has been widely used in the therapeutic treatment of the spine, orthopedics, arthroscopy and trauma.