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.
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.
