CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)
CryoLife, Inc. has announced that the FDA has approved the company’s Investigational Device Exemption to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. BioFoam will be used to seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent.
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