Q+A on Pebax® SA01 MED grades
Philadelphia, PA, USA – (July 12, 2010) – The Pebax® SA01 MED grades sold in the US and the Pebax® SA01 grades sold in Europe are the same. The US market has been the primary market for medical application thus far. As the use of minimally invasive products is continuously growing in other parts of the globe, Arkema is undertaking a harmonization of its product offering range to the medical industry. As a result of this harmonization, Pebax® SA01 MED will be globally available including Europe and Asia.
What is the recent press release on June 4th about?
The recent press release is about Arkema’s strategic commitment to the medical market with the launch of Pebax® SA01 MED for all < 30 days bodily contact medical application effective Jan 1, 2011.
Will there be any changes to chemistry, composition, proven assets or process used for Pebax® SA01 MED that would requirement notification to the medical OEMs?
NO, there will be no such changes at all.
Will there be any changes to Pebax® SA01 MED nomenclatures?
NO, there will be no changes to Pebax® SA01 MED nomenclatures.
Will Pebax® SA01 MED grades continue to carry USP Class VI certification?
YES, Pebax® SA01 MED will continue to carry USP Class VI certification.
Will Pebax® SA01 grades continue to carry USP Class VI certification in Europe?
NO, Pebax® SA01 will not carry USP Class VI certification in Europe after Jan 1, 2011.
Will Pebax® SA01 MED grades continue to be recommended for < 30 days bodily contact Minimally Invasive Device (MID) applications?
YES, Pebax® SA01 MED grades will continue to be recommended for < 30 days bodily contact applications, but they are not approved for longer term permanent implants.
Is Pebax® SA01 MED the only product endorsed by Arkema for the medical market?
YES, Pebax® SA01 MED will be the only product for the medical market with full endorsement by Arkema.
Where can customers purchase Pebax® SA01 MED grades?
Pebax® SA01 MED grades can be purchased through distribution channels that may differ from region to region. For North America, Arkema has appointed Foster Corporation as the exclusive distributor for Pebax® SA01 MED grades. For both Europe and Asia, Arkema will appoint preferred distribution channels for Pebax® SA01 MED and will issue a related communication in the second half of 2010.
What will be the incentive for OEMs to follow the harmonization efforts of Arkema?
Arkema will continue to develop its product range for medical market and will strive for continuous improvement, in close collaboration with the OEMs and the medical industry.