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news.Biomaterials company SyntheMed said that an FDA asvisory committee has recommended approval of Repel-CV adhesion barrier for use in pediatric patients who are likely to need secondary open heart surgery.
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The system devices advisory panel also recommended the development of additional safety data as a basis for expanding the indicated use to include adult patients.
Dr Eli Pines, vice president of research, said: “We are pleased with the panel’s recommendation to approve Repel-CV and we look forward to discussions with the FDA on securing approval to market Repel-CV for the initial indication. We will also immediately seek FDA approval to initiate the adult clinical study.”