Now, with approvals in three major South American markets, OXPEKK®-IG is firmly positioned to be a lead material on the continent.
South Windsor, CT (PRWEB) November 29, 2011
Oxford Performance Materials is pleased to announce that an innovative spinal device made from OXPEKK®-IG has recently received regulatory approvals in two South American countries. Following great success in Europe, the FILL-SQUALE™ cervical cage has been approved for long-term implantation by ANMAT and DIGEMID, the regulatory authorities in Argentina and Peru, respectively. The device is produced by Orthopaedic & Spine Development, and these approvals mark the first entrance of OXPEKK®-IG and OSD devices into these dynamic new markets.
“OSD has been a long term partner with OPM,” said Scott DeFelice, President of OPM. “It is rewarding to advance our global positions in this cooperation.” OPM’s first regulatory approval in the region came in 2010, with the ANVISA (Brazil) approval of another spinal implant device. Now, with approvals in three major South American markets, OXPEKK®-IG is firmly positioned to be a lead material on the continent.
OPM’s OXPEKK®-IG polymer is a high-performance, ultra-pure thermoplastic with properties very similar to bone. The produce is polyetherketoneketone (PEKK) and is within the class of polyaryletherketone polymers (PAEK). OXPEKK®-IG polymer has been extensively implanted worldwide. The produce 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 Master File, without any access fees. Given the implantation history of OXPEKK®-IG polymer products, there are now numerous clinically relevant studies available for reference.
Founded in 2005, Orthopaedic & Spine Development (OSD) is a French manufacturer specialized in developing and selling implants for spine and extremities. Being mainly owned by its founders, this independence allows OSD to develop long-term projects while staying strongly R&D oriented.
With the aim to meet the surgeons’ requirements, OSD is continuously searching for innovative solutions by co-developing its implants with leading French surgeons. Through their support, OSD is constantly looking for a more ergonomic design and safer implants and instruments. Thus far, OSD’s implants are being sold in more than 25 countries. Most recently, their spinal cages have obtained regulatory approvals in Argentina and Peru.
Founded in 2000 OPM is a privately held advanced materials and manufacturing technology company focused on developing solutions that enhance fundamental human sustainability.
For more information, please visit http://www.oxfordpm.com