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EVARREST, sealant matrix based on human fibrinogen and thrombin
SUMMARY OF THE TRANSPARENCY COMMITTEE OPINION
Opinions on drugs -
Posted on
Apr 25 2016
Reason for request
Inclusion
No clinical benefit demonstrated in current surgical treatment in improving haemostasis when standard surgical techniques are insufficient.
- EVARREST has Marketing Authorisation as supportive haemostatic treatment when standard surgical techniques to improve haemostasis are insufficient.
- It comprises a dry layer of human fibrinogen and thrombin and a flexible and resorbable matrix, the absorption of which is considered complete after about 8 weeks.
- EVARREST, as an adjunct to standard methods, improves the percentage success of perioperative haemostasis in the course of elective surgery. However, its contribution in reducing morbidity and mortality (in particular transfusions, repeat surgical procedures, operating time, duration of hospitalisation, deaths) has not been demonstrated.
- In the absence of studies comparing EVARREST with another fibrin sealant or thrombin-based product, its therapeutic benefit cannot be assessed in relation to the alternatives used in practice.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
- |
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