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It’s a peak week for PEEK news. Following the announcement earlier this week that FDA cleared the first foot-and-ankle implant made from Invibio Biomaterial Solutions’ PEEK-Optima HA Enhanced polymer comes word that Solvay’s Zeniva PEEK was selected by medical device OEM KiSCO Co. (Kobe, Japan) for the first non-metal lumbar cage for vertical interbody fusion made in Japan. The 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 selected Zeniva ZA-500 PEEK because of its performance properties, including fatigue resistance and a modulus similar to bone, said Solvay in a press release distributed today. KiSCO also wanted an implantable medical material that could facilitate post-operative diagnosis. PEEK is an alternative to titanium, which is typically used in this application, 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 spinal cages allow surgeons to use a screw-and-spacer mechanism to make these necessary adjustments.
During clinical trials, the material enabled KiSCO’s spinal cage to maintain structural stability even when screws were used to expand the spacers.
Solvay’s ability to provide quality data for biological evaluation and its responsiveness facilitated the regulatory process, allowing KiSCO to secure approval from PMDA in a short period of time, said the company.
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