CryoSeal autologous sealant approved in US for use in liver resection:
This article was originally published in Clinica
Executive Summary
The US FDA has cleared ThermoGenesis' CryoSeal FS system, an autologous fibrin sealant, for use as an adjunct to haemostasis in liver resection surgery. The Rancho Cordova, California company's product, which is made entirely from a patient's own plasma, has received a premarket approval (PMA). The CryoSeal product is already approved for use in any surgery in the EU, having received the CE mark in 2001, and is awaiting approval in other countries including Brazil, Japan, Korea, Mexico, Russia and Taiwan.