Belgian company Omrix Biopharmaceuticals SA has been granted its firstregulatory approval, in Israel, for its second-generation fibrin sealant product Quixil. The approval is the first to be granted for a new fibrin sealant for several years and "marks the entry of a new class of safer, more effective and more convenient adhesive for use in surgery," according to the company.
The approval was based on pivotal trials conducted in Israel and the UK, which found that Quixil reduced bleeding in total knee and hip replacement surgery. The sealant also cut the need for blood transfusions, says Omrix. Quixil differs from other sealants in that it has a double virus inactivation step and is available in a liquid rather than a lyophilized form, and can be ready for application more quickly.
The firm added that the approved indications for the sealant should be expanded to include other surgeries once data from recently-completed European studies are submitted to the regulatory authorities. Applications in the European Union and USA will be filed in the next few months.
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