Anulex: Preservation and Anular Repair

Your surgeon may choose to...
Preserve and repair the anulus after a surgical discectomy procedure for a herniated disc. This may reduce reoperations and improve patient outcomes by:

• Enabling less extensive disc material removal during the discectomy procedure to preserve the natural anatomy to the greatest extent possible.^7-11

• Providing a barrier to restrict nuclear material from re-extruding and compressing on the nerve root causing pain.^12-18

• Reducing inflammation and scar formation of the nerve root and surrounding tissues.^19-22

Literature referenced herein represents independent study of anular repair techniques and was not submitted for review by the Food and Drug Administration at the time of Premarket Notification. By providing these references, the company is not intending to make or imply any additional claims beyond those currently cleared and within the 501(k) label for the device. The physician should carefully read the data to determine its relevance to the individual patient. The cleared indication reads as follows: The Xclose Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

For complete Xclose and Inclose product disclosures click the links below:
Xclose Product Disclosure
Inclose Product Disclosure