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Frequently Asked Questions about GORE® PRECLUDE® MVP® Dura Substitute

Are there any special handling or storage requirements for GORE® PRECLUDE®MVP® Dura Substitute?

GORE® PRECLUDE® MVP® Dura Substitute does not need to be kept in any special storage conditions. There is no expiration date for the product function or characteristics. Clean, unused, and undamaged portions of the GORE PRECLUDE® MVP® Dura Substitute may be resterilized up to three times using methods and parameters described in the Instructions for Use.

Can a watertight closure be achieved with GORE® PRECLUDE® MVP® Dura Substitute?

GORE® PRECLUDE® MVP® Dura Substitute incorporates a proprietary sealing layer that facilitates an immediate watertight closure. In cases where enhanced biological fixation and sealing are desirable, GORE PRECLUDE® MVP® Dura Substitute may be implanted using an underlay technique. Size the material to overlap the defect by approximately 1 cm tucking the GORE PRECLUDE® MVP® Dura Substitute under the edges of the native dura. Suture in place per normal standard of care.

Can GORE® PRECLUDE® MVP® Dura Substitute be used in the spine?

GORE® PRECLUDE® MVP® Dura Substitute may be used in the spine for repair of the dura mater during neurosurgery.

How long has GORE® PRECLUDE® MVP® Dura Substitute been used clinically?

GORE® PRECLUDE® MVP® Dura Substitute is the latest in a long line of GORE ePTFE membranes that have been used in neurosurgery since the 1980s. Numerous independent clinical evaluations have been published describing the excellent clinical results with GORE ePTFE membranes.

What advantage does GORE® PRECLUDE® MVP® Dura Substitute have over other material?

GORE® PRECLUDE® MVP® Dura Substitute has the versatility to be used in both traditional duraplasty closure applications as well as situations where biological fixation and sealing are desired.

What is the major benefit of GORE® PRECLUDE® MVP® Dura Substitute over biological dural grafts?

Since GORE® PRECLUDE® MVP® Dura Substitute is a synthetic material, there is zero risk of animal source disease transmission.

What kind of suture may be used with GORE® PRECLUDE® MVP® Dura Substitute?

GORE® PRECLUDE® MVP® Dura Substitute is compatible with any non- absorbable suture with a non-cutting needle.