The U.S. Food and Drug Administration has approved the first-ever spinal column implant made of Vestakeep polyethetherketone (PEEK).
Evonik announced that the associated pre-market notification 510(k) has been successfully issued, simplifying the process for future medical device manufacturers to get approval.
The FDA green light follows an intensifying effort by Evonik to penetrate medical markets with its engineering materials. Its PEEK medial plastics have already been approved for direct contact with the human body, for both short-term applications and in long-term implants in Europe and Asia, which have less demanding approval processes than the United States.
Evonik says the pitch for its PEEK is its biocompatible and biostable coupled with good processability for both injection molding and machining.
The company's product line for biostable or bioresorbable implants or medical devices will be shown at MedTec Europe (Feb. 26-28, Stuttgart, Germany) in Hall 1, Booth M62
Evonik became a major player in the bioresorbables global market in 2011 when it purchased Boehringer Ingelheim Pharma GmbH & Co., one of only two global suppliers of high molecular weight bioresorbable polymers with an interval viscosity greater than two, that is that are melt processable. The other company is Purac, which is building a U.S. plant for its very pure lactide products.
The entire product portfolio of standard and customized polymers used in the manufacturing of medical devices and pharmaceutical formulations was transferred to Evonik. Based on lactic and glycolic acids, the Boehringer polymers are fully biodegradable in the body.
Evonik also sells transparent polyamides under the Trogamid brand to the medical industry. They consist of partly aromatic units that provide high rigidity and heat resistance. Substitution of the aromatic components with aliphatic monomers results in transparent polyamides with inherently better UV resistance, according to the company. Vestamid polyamide 12 is also used for medical applications.
Vestamid and Trogamid products are used in medical applications such as catheters for vessel therapy, surgical instruments, and stopcocks for infusion equipment.
Evonilk rebranded its premium medical-grade plastics as the "Care" series last March. They are biocompatible and satisfy the requirements of USP Class VI.