ThermoGenesis answers FDA questions
ThermoGenesis (Rancho Cordova, California) reported that the company has responded to the FDA's questions on its pre-market approval (PMA) application for its CryoSeal Fibrin Sealant (FS) system as an adjunct to hemostasis in liver resection surgeries.
The CryoSeal FS system is an automated device and companion sterile blood processing disposable used to prepare surgical fibrin sealants from a patient's own plasma in about an hour.
If approved, CryoSeal would be the only system in the U.S. market that could produce fibrin sealant from the patient's own blood (autologous), the company said. The FDA will determine the process, timing and results of any regulatory submissions, ThermoGenesis added.
ThermoGenesis develops automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products.