DuraSeal™ Spine Sealant Receives FDA Approval

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Sep 2009 - 0:00 PDT

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Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal™ spine sealant for use in the United States. This is the first product that has been approved specifically as an adjunct to suturing for intra-operative dural sealing in spine procedures.

DuraSeal spine sealant has been shown in a U.S. pivotal study to deliver an intra-operative watertight seal 100% of the time1. In the same study, commonly used sealing methods achieved an intra-operative watertight seal only 64% of the time. The remaining patients were treated with additional products and/or techniques to achieve a watertight seal.

"DuraSeal continues Covidien's dedication to scientific, evidence-based innovation that improves patient outcomes," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien.

"There's a critical need to resolve cerebrospinal fluid leaks within the OR. We cannot continue with the procedure until we've dealt with the leak," said Dr. Neill Wright, Associate Professor, Neurological & Orthopedic Surgery, Washington University School of Medicine.

The DuraSeal spine sealant is designed to be a quicker solution than conventional sealing methods, for surgeons who are faced with a dural tear:

- The fast-acting, self-contained sealant gives surgeons the only FDA-approved, easy-to-use solution for sutured dural tears, which occur in nearly 10% of all spinal surgeries.

- The DuraSeal spinal sealant only takes two minutes to prepare for use and three seconds to set, so surgeons can quickly complete an intra-operative dural seal.

- The same formulation was approved by the FDA in 2005 and is currently on the market for cranial procedures. Since its approval, more than 210,000 units have been sold worldwide. DuraSeal Cranial and DuraSeal Xact ABS (spine) are also available in Europe and other international markets.

Covidien expects to launch DuraSeal spine sealant in the next few weeks.

1 DuraSeal™ Spine Sealant instructions for use. REF:20-4300; 1022286.

Source
Covidien