SangStat has received marketing clearance from the Food and Drug Administration for Celsior, which SangStat describes as "the first standardized flushing and cold storage solution for donor hearts" in the United States.
Celsior is expected to be launched in the United States in September, and it is already being sold for organ preservation in Europe.
"The pivotal multicenter clinical trial for Celsior in cardiac transplantation was conducted at 18 centers in the United States and Canada. The study compared the safety and efficacy of Celsior flush and cold storage solution to the best local standard flush and cold storage solution(s) used by the participating cardiac transplant centers. This benchmark study showed that Celsior is as safe and effective as the other solutions tested," SangStat said in a statement (www.sangstat.com/press/press_release99-22.html). The company also said that it plans to conduct clinical trials to study the use of Celsior for lung transplantation and for other organs.
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