Regulatory Decision Summary for Evicel

Evicel is a fibrin sealant authorized for support of hemostasis in surgery. The present indication expands the indication to the support of dural suturing to obtain a water tight closure. Evicel does not contain tranexamic acid, thus avoiding its potential for neurotoxicity. Risk mitigation has been addressed for the product in previous submissions, most recently in regard to the risk of air/gas embolism when spraying under pressure. The use of the product in the indicated neurosurgical settings for sealing the dural suture line did not result in unexpected adverse events. Monitoring will continue as use increases.

The pivotal clinical trial shows that application following suturing of the dura is more effective than additional sutures in preventing further leakage when assessed at the time of surgery in ideal suturing conditions. The benefits are not known, however, in other dural suturing situations where a sealant might be considered, including if the size of the defect is >2mm, if dural patches are used or following radiation or chemotherapy. These limitations are indicated in the updated Product Monograph in the "Use in Neurosurgery" section.

The serious adverse events (SAEs) when assessed up to 30 days following surgery in the Evicel group and the suture group are comparable if rhinorrhea is excluded from the Evicel group. Other SAEs include hygroma, cerebrospinal fluid (CSF) leaks, meningitis. In some cases it is uncertain whether the SAE should be attributed to the study product or the intracranial procedure. The small number of adverse events (AEs) and subjects and the different types of intracranial surgeries in the trial make it difficult to assess causality of the AEs.

In summary, the study submitted shows that Evicel is superior to additional sutures in sealing the dural suture line in ideal suturing conditions when assessed at the time of surgery. The risk of adverse events that could be due to later leakage is not clear because of the small number of events and subjects. At this time, the benefit/risk is considered favourable for this indication.