New Heart Storage Solution Cleared by FDA

Celsior – the first standardized flushing and cold storage solution for donor hearts was cleared by the Food and Drug Administration for use in the United States last year.

According to Sangstat, the company responsible for Celsior, a benchmark study showed that Celsior was a safe and effective as the other solutions tested. 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 used by the participating cardiac transplant centers. The company also said that it plans to conduct clinical trials to study the use of Celsior for lung transplantation and for other organs.

Celsior comes in at a time when early graft loss remains a significant problem associated with cardiac transplantation and damage to the heart tissue can occur due to inadequate preservation. Effective organ preservation includes initial flushing of the heart tissues during the retrieval process and cold storage while the donor heart is transported to the recipient. Recent surveys have noted that there was no consistent accept standard flushing and cold storage solution for cardiac transplantation in the United States. Historical use and regional influences are the primary factors in determining which solution is used at a s transplant center. Other than Celsior, none of the other solutions currently used has been cleared by the FDA for flushing and cold storage of donor hearts.

Celsior – the first standardized flushing and cold storage solution for donor hearts was cleared by the Food and Drug Administration for use in the United States last year.

According to Sangstat, the company responsible for Celsior, a benchmark study showed that Celsior was a safe and effective as the other solutions tested. 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 used by the participating cardiac transplant centers. The company also said that it plans to conduct clinical trials to study the use of Celsior for lung transplantation and for other organs.

Celsior comes in at a time when early graft loss remains a significant problem associated with cardiac transplantation and damage to the heart tissue can occur due to inadequate preservation. Effective organ preservation includes initial flushing of the heart tissues during the retrieval process and cold storage while the donor heart is transported to the recipient. Recent surveys have noted that there was no consistent accept standard flushing and cold storage solution for cardiac transplantation in the United States. Historical use and regional influences are the primary factors in determining which solution is used at a s transplant center. Other than Celsior, none of the other solutions currently used has been cleared by the FDA for flushing and cold storage of donor hearts.