TAGS: Medical
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.
Zeniva® ZA-500 PEEK - Compliance with ISO 13485
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.
Kisco’s Advanced Spinal Cages
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.”
Source: Solvay