The “KetaSpire” PEEK portfolio of Solvay Specialty Polymers (Alpharetta, Georgia / USA; www.solvayspecialtypolymers.com) continues to profit from strong demand in high performance applications globally. Most recently, the US subsidiary of the Belgian Solvay Group (Brussels; www.solvay.com) announced that “Zeniva,” one of four PEEK products in its “Solviva” biomaterials portfolio, has successfully passed biocompatibility testing at the China Food and Drug Administration’s Tiainjin Medical Device Quality Supervision and Inspection Center.

Approval by the Tianjin inspection centre is especially significant, the company stressed, as this is regarded as the most influential testing agency in the field of orthopedics. As part of the rigorous test, which took over a year to complete, properties of Zeniva, such as sensitisation, intracutaneous toxicity, acute systemic toxicity, sub-chronic toxicity, genotoxicity and bone implant compatibility, were examined to ensure biological safety in the human body.

“This essential recognition will help local medical OEMs to gain regulatory approval from the China Food and Drug Administration for their implantable devices,” said Kendra Shoulders, director of global regulatory affairs for healthcare at Solvay Specialty Polymers. Luke Du, the US company’s managing director Asia and executive vice president, added that the positive biocompatibility assessment furthers its commitment to both national and multi-national medical OEMs and reinforces its position as a strategic supplier to the Chinese healthcare industry, where Solvay has been active for more than 25 years.

The Solviva biomaterials portfolio has been commercially available in China since 2013. As Zeniva has a modulus very close to that of cortical bone, plus excellent fatigue resistance and toughness, Solvay said it is suitable for use in implantable medical devices for spine, orthopedics, cardiovascular and dental applications. The biomaterials line also encompasses “Veriva,” a PPSU claimed to combine toughness with transparency and excellent biocompatibility, along with its “Eviva” PSU, a transparent, biocompatible polymer said to offer high strength and toughness.

In another boost for Solvay’s PEEK brand, the company announced that the KetaSpire-based “Zellamid” 1500 product line of an Austrian customer, extruded engineering plastic and high performance polymer stock shapes manufacturer Zell-Metall (Kaprun; www.zellamid.com), has passed migration testing for food contact materials according to EN 1186:2002 and EU 10/2011. Separately, advanced cabling manufacturer Optacore (Ljubljana / Slovenia; www.optacore.si) has chosen Solvay’s “KT-851 NT” PEEK and its “AvaSpire” AV-630 NT PAEK to coat its two new “OptaGuide HT” optical fibre systems used for high-speed data networking and demanding sensor applications in construction, oil and gas and other extreme end-use environments.