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Dural sealant to enter pivotal US trial:

This article was originally published in Clinica

Executive Summary

Confluent Surgical is to start a pivotal US study of its dural sealant for preventing cerebrospinal fluid (CSF) leaks, which are associated with neurosurgical and spinal orthopaedic procedures. The FDA has given the Waltham, Massachusetts firm the go-ahead to test its product - DuraSeal - as an adjunct to dural closure in a prospective, multicentre study. As for plans to market the product outside the US, Confluent intends to use results from a recently announced assessment to support an application to CE-mark and launch the product in Europe. The data revealed a 100% intraoperative and 96% post-operative success rate in preventing CSF leak, the company said.

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