Transplant Medicine
Enrollment in trial of new fibrin sealant system for liver transplant complete
Published in Medical Letter on the CDC and FDA, July 31st, 2005
This pivotal trial evaluated the safety and efficacy of the fibrin sealant prepared by the CryoSeal FS System as an adjunct to hemostasis for patients undergoing liver resection surgery. The data will be compiled and included in a PMA (premarket notification) submission expected to be filed in calendar 2005. The review process after a PMA submission typically takes 6 months.
U.S. Food and Drug Administration (FDA) clearance will allow the company to address...
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