Blood volume expander gets FDA nod

January 3, 2008

Voluven is approved for blood loss

Voluven, manufactured by German company Fresenius Kabi, has received an FDA approval for restoring blood volume following surgery. The new intravenous product contains 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection and has proven to be as safe and effective in expanding blood volume as Hespan (B. Braun Medical) during orthopedic surgery. The new solution was also studied in newborns and infants. The synthetic starch molecules contained in the product do not dissolve in water and are linked together and combined with a salt solution in a concentration similar to human blood. According to the company, a clinical trial to study Voluven in patients with sepsis is planned.

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