FORT SASSKATCHEWAN, ALBERTA, CANADA - Westaim Biomedical, a division of The Westaim Corporation, today announced that its Acticoat® Antimicrobial Barrier Dressing for burn wounds has received CE mark (Conformité Européenne) certification, which is required for all medical devices sold in Europe.To achieve certification, Westaim Biomedical and its processes were audited against directives set out by the European Community to approve a company’s quality system and products. Meeting these requirements also qualifies Westaim for ISO 9001 certification – the International Organization for Standardization’s registration for quality in design, manufacturing and service.
“CE mark certification is indicative of Westaim’s commitment to quality and safety in manufacturing and is an important step in our commercialization strategy,” said Westaim Biomedical President Dr. Michael Raymont. “Our Acticoat AB and SCD dressings give health care providers the ability to prevent wound infections with greater efficacy and convenience. Our marketing efforts are underway in the U.S. and Canada, and we can now begin to develop a European market strategy.”
The dressing continuously releases silver, which is well known for its antimicrobial properties. The sustained release of bactericidal silver provides powerful protection against infection for several days and reduces the number of dressing changes. The antimicrobial action is very rapid, and is effective against an extremely broad range of bacteria including resistant strains. In addition, the non-adherent properties of the dressings ease removal and reduce patient pain.
Initially, the technology is being used for burn wound dressings. Other potential uses include chronic wound care for diabetic and pressure ulcers, urological and central venous catheters and orthopaedic and other implants.
Acticoat® AB is accepted as a medical device in the United States and Acticoat® SCD in Canada. They were launched as commercial products in March 1998.
Westaim Biomedical has completed clinical and outcome studies comparing its dressing to other burn wound treatments. The studies have demonstrated that Acticoat® AB and SCD reduce the frequency of burn wound sepsis, work faster, and improve patient comfort.
The Westaim Corporation’s portfolio of technology businesses consists of Westaim Biomedical, Advanced Display Technologies and Surface Engineered Products. Its industrial businesses produce coin blanks, aerospace materials and chemical products. A TSE 300 company, Westaim’s common shares are listed on The Toronto Stock Exchange, The Alberta Stock Exchange and the Montreal Exchange under the trading symbol “WED”.
For more information contact: Tony Johnston Senior Vice President, Corporate Affairs (403) 803-6301 tjohnsto@westaim.com www.westaim.com
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