CryoLife has enrolled the first patient in a US investigational device exemption trial for its BioFoam surgical matrix, designed for cellular aggregation and enhanced haemostasis.
BioFoam, a protein hydrogel biomaterial, will be used as an adjunct to achieve haemostasis on newly resected liver parenchyma.
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The prospective, multicentre and randomised feasibility study will enrol 20 people, ten in each treatment group, to assess safety outcomes of BioFoam compared with a standard topical haemostatic agent.
The company also plans a follow-on pivotal study on successful completion of the feasibility study and subsequent US Food and Drug Administration and Department of Defence approvals.
The pivotal study will enrol a total of 164 people, 82 in each treatment group, and the data derived from it will be used to support a premarket approval application for BioFoam in the US.
The primary objective of the pivotal study will be to demonstrate a decrease in the time to achieve intraoperative haemostasis.
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