Sep 8 2010
Oxford Performance Materials (OPM) is pleased to announce that a medical device produced with its OXPEKK®-IG polymer has received ANVISA clearance.
ANVISA is the regulatory authority for the Brazilian market. The approved device is produced by Sintea Plustek and is a long-term spinal implant. This regulatory clearance now establishes a path forward for OPM to sell its products in the highly dynamic Brazilian market.
OXPEKK-IG device VIKING
“The pursuit of this important milestone now completes the major elements of our regulatory strategy for the Americas. We are very pleased to bring our products and technologies to the fast growing Brazilian market” said Scott DeFelice, President and CEO of OPM. To date OPM has been selling OXPEKK®-IG polymer extensively in Europe, Middle East and South America on the basis of numerous CE mark and other national approvals, including recently, the desirable Korean market by gaining approval from the Korean Food and Drug Administration (KFDA). In addition a device produced with OXPEKK®-IG polymer was also cleared by the U.S. Food and Drug Administration (FDA) opening up the US market.
“The Viking device made from OXPEKK®-IG polymer has been very successful for Sintea Plustek, and we are pleased that the global expansion of this novel product now continues into South America.” said Franco Ronchi, Technical Manager of Sintea Plustek.
OPM’s OXPEKK®-IG product is a high-performance, ultra-pure thermoplastic with properties very similar to bone. The product is polyetherketoneketone (PEKK) and is within the class of Polyaryletherketone polymers (PAEK). OXPEKK®-IG polymer has been extensively implanted worldwide. The product is supported by comprehensive ISO 10993 biocompatibility and purity data. The biocompatibility data is available directly from OPM or in the firm’s extensive FDA masterfile, without any access fees. Given the implantation history of OXPEKK®-IG polymer products, there are now numerous clinically relevant studies available for reference.