OPM clearly presented the technical competence, diverse product offering and collaborative business model that we were looking for. In the eight months it took to get this 510(k) Clearance, the OPM team diligently supported this effort.
Enfield, CT (PRWEB) July 15, 2010
Oxford Performance Materials (OPM) is pleased to announce that a long-term implantable medical device manufactured with its OXPEKK®-IG polymer has received 510(k) Clearance by the United States Food and Drug Administration (FDA). The device is produced by Kent Medical Devices (KMD) from OPM’s radio-opaque OXPEKK®-IG polymer containing barium sulfate. This regulatory clearance now establishes a path forward for OPM to sell its products in the highly desirable US market.
“The pursuit of this important regulatory milestone has been a long-term focus of OPM. Though we certainly would have liked to have seen this process move a little faster, we take great comfort that the diligence required by us from the FDA has refined and improved many elements of our business over this time” said Scott DeFelice, President and CEO of OPM. “With the US regulatory pathway becoming more clearly defined, we now look forward to a timely realization of our associated commercial objectives.” To date, OPM has been selling extensively in Europe, Middle East and South America on the basis of numerous CE Mark and other national approvals. Most recently, OXPEKK®-IG polymer also penetrated the desirable Korean market by gaining market clearance from the Korean Food and Drug Administration.
The FDA cleared KMD-Mark1 is an implantable device used to radiographically mark biopsy and other soft tissue sites during and after surgical procedures. “When looking for a material supplier, OPM clearly presented the technical competence, diverse product offering and collaborative business model that we were looking for. In the eight months it took to get this 510(k) clearance, the OPM team diligently supported this effort. We are pleased now to explore more projects with OPM,” said James Kent, President and CEO of KMD.
OPM’s OXPEKK®-IG polymer 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.
Kent Medical Devices, Inc. (KMD) was founded in 2008 to develop, manufacture and market proprietary medical devices. KMD is currently developing a line of implantable devices for diagnostic and treatment purposes. KMD is privately held and based in Minneapolis, MN, USA.
Founded in March 2000, OPM has rapidly become an industry leader in the ultra-high performance thermoplastic polymers market. The firm’s versatile OXPEKK® polymers are currently being used in medical, space and defense, semiconductor and industrial markets worldwide.
OPM is ISO 9001:2000 and ISO 13485:2003 certified.
In February 2009 OPM was acquired by France’s leading chemicals producer, Arkema. For additional information, please visit http://www.oxfordpm.com or http://www.arkema.com/opm.
A global chemical company and France’s leading chemicals producer, Arkema consists of three strategically related businesses: Vinyl Products, Industrial Chemicals, and Performance Products. Arkema reported sales of 4.4 billion euros in 2009. Arkema has 13,800 employees across 40 countries and six research centers located in France, the United States and Japan. With internationally recognized brands, Arkema holds leadership positions in its principal markets. For additional information, please visit http://www.arkema.com
OXPEKK® is a registered trademark of Oxford Performance Materials Inc.