EVICEL, sealant based on human fibrinogen and thrombin

The Transparency Committee does not recommend reimbursement as suture support for suture line sealing in dura mater closure as the clinical benefit is insufficient

• EVICEL is the only fibrin sealant with Marketing Authorisation in neurosurgery, as suture support for suture line sealing in dura mater closure.
• EVICEL improves the intraoperative watertight closure when the gap between the margins of the suture line is less than 2 mm after the primary closure, but its contribution to the reduction in associated postoperative complications (CSF leakages and infections) has not been demonstrated.
• No comparison with a supportive treatment (such as a medical device) in situations with the highest risk of postoperative complications is available.
• Consequently, EVICEL has not been shown to be beneficial in therapeutic management in the current state of the data.