Solvay’s Zeniva® PEEK was selected by KiSCO Co. for the first non-metal lumbar cage for vertical interbody fusion made in Japan. This advanced spinal cage is commercially-available only in Japan, where that country’s Pharmaceuticals and Medical Devices Agency (PMDA) approved the implantable medical device for production in October 2018. KiSCO began selling the advanced spinal cage in February 2019.
KiSCO machined the spinal cage from Zeniva® ZA-500 PEEK, which Solvay manufactures in compliance with ISO 13485. The performance properties of Zeniva® PEEK, including excellent fatigue resistance and a modulus similar to bone, were key factors in material selection. KiSCO also wanted an implantable medical material that could facilitate post-operative diagnosis. As an alternative to titanium, a common spinal cage material, PEEK is attractive because its radio transparency allows for easy visualization in medical X-ray and MRI imaging.
The primary function of a spinal cage is to maintain the proper intervertebral angle and height until spinal fusion occurs. However, spinal cages also need to accelerate bone fusion and support adjustments during surgery. KiSCO’s advanced spinal cages allow surgeons to use a screw-and-spacer mechanism to make these necessary adjustments.
During clinical trials, Solvay’s Zeniva® PEEK enabled KiSCO’s advanced spinal cage to maintain structural stability even when screws were used to expand the spacers. Solvay’s responsiveness and ability to provide quality data for biological evaluation facilitated the regulatory process so that KiSCO could secure approval from PMDA in a short period of time.
“Solvay is pleased that our ongoing support was instrumental to the successful development of KiSCO’s first PEEK spinal cage for the Japanese medical industry,” said Kiyomi Ando, sales development manager for Healthcare, Japan at Solvay’s Specialty Polymers global business unit. “Our uniquely collaborative approach differentiates us from other PEEK suppliers in this industry and allowed us to pool our respective capabilities and resources with KiSCO to meet an important need in the medical marketplace.”
Solvay’s Zeniva® PEEK is commercially available worldwide.
® Zeniva is a registered trademark of Solvay
KiSCO Co., Ltd., established in 1968, is a company of the development and sales for the orthopedic category, especially focusing on trauma and spine products, which supplies various innovative devices to the market. Based on KiSCO’s company mission, “KiSCO-people creating innovative devices and providing high-quality service to medical experts for better health worldwide,” the company is always trying to improve the QOL of patients and to meet our customers’ satisfaction by utilizing our core competency in the healthcare area.
Learn more at www.kisco.jp.
Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its lightweighting materials promote cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 62 countries. Net sales were €10.3 billion in 2018, with 90% from activities where Solvay ranks among the world’s top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris Bloomberg: SOLB.BB – Reuters: SOLB.BR), and in the United States its shares (SOLVY) are traded through a level-1 ADR program. Financial figures take into account the planned divestment of Polyamides.
Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, ultra-high performance aromatic polymers, and high-barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.
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