Asahi Kasei Files PMA for ThermoGenesis' CryoSeal in Japan
ThermoGenesis announced that Asahi Kasei Medical,
a supplier of medical products and disposables and the exclusive licensed distributor
of the CryoSeal System in Japan, has completed their premarket approval (PMA)
submission to the Ministry of Health, Labor and Welfare (MHLW) following completion
of their clinical trial on cardiovascular, orthopedic, neurosurgery and esophageal
surgery patients. The clinical trial was designed to study efficacy, safety
and usefulness of the "All-Autologous" CryoSeal Fibrin Sealant System.