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New medical device coating approved for use in Japan
- Publisher：
- Publication：2013/3/18
Novozymes Biopharma has announced approval in Japan for a medical device using Recombumin Alpha, a recombinant human albumin product.
Recombumin Alpha is used by one of the company's customers Maquet in a version of its Bioline Coating, which has already received regulatory approval and is being used around the world.
The latest approval represents the first for a medical device product in Japan using Novozyme Biopharma's Recombumin portfolio.
The company has been working with Maquet to develop products over the past decade, with the Bioline Coating developed by Maquet promising to improve the biocompatibility of extracorporeal circulation system devices, including oxygenators.
This is particularly important in cases where these devices come into contact with blood, such as during heart surgery.
According to Novozymes, the use of Recombumin Alpha in the Bioline Coating allows for greater safety and less chance of contamination or impurities.
Dr Wolgang Rencken, president and chief executive of Maquet, said: "With Novozymes' rAlbumin, Maquet is now able to offer our highly biocompatible Bioline Coating in Japan.
"Reducing negative side effects on blood when it comes into contact with foreign surfaces, such as polycarbonates or tubings, has always been one of Maquet's focus areas in extracorporeal circulation. We are very happy to offer this advantage to our customers and especially their patients in Japan. "