FDA approves biodegradable blood-clotting patch

The FDA today approved the first absorbable fibrin sealant patch designed to prevent mild and moderate bleeding from small blood vessels during CV surgery.

The surgical patch (TachoSil, Nycomed Austria GmbH) is made from a dry collagen sponge extracted from horse tendons and coated with fibrinogen and thrombin — two proteins that react to produce fibrin, a protein necessary for blood clots to form. Within four to six months, the biodegradable patch breaks down within the body.

“This approval provides an additional tool for surgeons to help control mid and moderate bleeding from blood vessels during CV surgery when standard surgical techniques are ineffective or impractical,” Karen Midthun, MD, acting director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA press release.

Data from a premarketing clinical trial that involved 119 CV surgery patients showed that the patch stopped bleeding in 74.6% of patients assigned to it compared with 33.3% of patients in the control group.

Plasma donors who contribute patch components are screened and tested for bloodborne diseases, and the fibrinogen and thrombin that are used to manufacture the patch undergo a process to remove impurities. The manufacturers use a similar process to screen and remove impurities including equine viruses from the horse collagen.

The FDA warned that hypersensitivity or allergic reactions to product components may occur; however, the agency noted that there were no statistically significant differences in adverse reaction rates between the study and control groups.

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