Arkema is committed to provide the highest quality material for the medical market; this is why almost 10 years ago Arkema began to introduce MED grades for some of its Specialty Polyamides products. An extensive range of MED grades is now available for its main product lines (Pebax® SA 01MED, Rilsan® MED, and Rilsamid® MED) that Arkema will sell exclusively in the medical devices market worldwide.
Pebax, Rilsan and Rilsamid grades that include “MED” in the nomenclature are considered by Arkema to be medical grades. Although identical in chemistry, MED grades offer several benefits for medical applications over standard grades. MED grades are USP Class VI-tested and have distinct qualifying specifications, including viscosity, gel rating, and moisture content. Additionally, Arkema ensures consistency in MED products. For instance, Pebax , Rilsan and Rilsamid MED grades have dedicated manufacturing locations, which is not the case for standard grades. Also, Pebax, Rilsan and Rilsamid MED come with a 12 months advance notification of change to specifications or manufacturing location.
Products that do not have MED in their name are not recommended by Arkema for use in medical applications, in accordance with Arkema’s medical policy. Arkema will support its customers to manage the transition to the MED during the first year. At the end of this transition period, on January 1st. 2014, only the MED grades will be available for use in medical applications.
Pebax SA 01 MED polyether block amides are thermoplastic elastomers with a wide range of flexibility, depending of the soft block ratio, while keeping remarkable processing ease, and excellent mechanical and chemical resistance. This combination of properties makes them an excellent choice for medical tubing and angioplasty balloons. Pebax SA MED grades have become a standard in cardiovascular devices, including percutaneous transluminal coronary angioplasty (PTCA) catheters.
Rilsan MED polyamide 11 and Rilsamid MED polyamide 12 are materials of choice for medical tubing and balloons in which “pushability” and burst strength are primary considerations, while still maintaining sufficient flexibility and elongation. Rilsan MED and Rilsamid MED are easy to use through usual polymer processing method such as extrusion and injection. Rilsan and Rilsamid MED is particularly highly prized for its ductility and burst pressure properties
To better serve this market, Arkema will keep on developing new grades for current and new medical applications, and is putting in place a specialized distribution network worldwide.
Consistent with this strategy, Arkema has appointed Velox GmbH as its exclusive distributor for the medical business development in Europe. Velox is a pan-European distributor with experience in the medical segment, with expertise to handle specific medical procedures. This will help ensure Arkema’s customers the highest level of confidence in a commercial partner.
In the North America region, Arkema continues its collaboration with the Foster Corporation, which has been distributing Arkema’s products to the medical market for several years.
For more information visit www.arkema.com/en/.