Confluent Surgical Inc announced that the U.S. Food and Drug Administration (FDA) has granted full approval of the Investigational Device Exemption (IDE) for the DuraSeal Dural Sealant System clinical study. The trial is a prospective, multi-center study designed to demonstrate safety and effectiveness of DuraSeal as an adjunct to dural closure for the prevention of cerebrospinal fluid (CSF) leaks. CSF leak is a serious complication of neurosurgical and spinal orthopedic procedures that occurs after the dura is closed, resulting in improper healing, infection and pain. Clinical studies outside of the U.S. have shown that DuraSeal eliminates the incidence of intra-operative CSF leak.

"This approval marks the beginning of a landmark study in dural sealing, designed to demonstrate the unique value of this therapy, which may provide neurosurgeons with the first approved treatment option for preventing CSF leak," said Rees Cosgrove, attending Neurosurgeon at the Massachusetts General Hospital, and primary investigator for the study.

"CSF leak represents a significant clinical event that can lead to further complications as well as the need to perform additional surgeries - to date, there is no treatment of choice. DuraSeal is an intriguing product and we are enthusiastic about its prospects," said Robert Spetzler, an investigator in the study and the Director of The Barrow Neurological Institute in Phoenix.

Confluent Surgical recently announced the results of their European DuraSeal experience, including a 100% intraoperative and 96% post-operative success rate in preventing CSF leak. These results will support the company's CE Mark and European launch of DuraSeal.