Tunneling Tool Cleared by FDA

A tunneling tool intended for single use during an implant procedure for treatment of epilepsy has been cleared by the U.S. Food and Drug Administration (FDA) as well as the European Union. Called the 400S, the new sterile tool replaces the nonsterile tool 400.

The stainless steel head in the enhanced device allows the tool to be provided sterile to the doctor for immediate use during implant procedures. Previously, sterilization of the device was required to be performed by the user prior to surgery. The 400S is the product of Cyberonics, Inc. (Houston, TX, USA; www.cyberonics.com) and is designed to work with the company's NCP System. The company develops and markets devices for the treatment of epilepsy and other debilitating neurologic disorders using vagus nerve stimulation.

Operating room teams should see increased efficiencies since they will no longer be required to complete lengthy sterilization procedures in the surgical theater, said Richard Kuntz, vice president, operations, for Cyberonics.