INDICATIONS, SAFETY, AND WARNINGS Durepair Dura Regeneration Matrix

Durepair™ is indicated as a dura substitute for the repair of the dura mater.

Safety

Durepair is manufactured from bovine skin, one of the purest sources of collagen that is commercially available. The source material is solely derived from cattle obtained in compliance with United States and European regulatory requirements.

Contraindications

• Durepair is not designed, sold, or intended for use except as indicated.
• Durepair should not be used for patients with a known history of hypersensitivity to collagen products.
• Durepair should be used with caution in regions where an infection exists.

Warnings and Precautions

PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings, and precautions given in this document to the patient.

• Do not resterilize as this may damage Durepair.
• Do not use if the product package is damaged or opened.
• Do not expose to any chemicals or substances other than room temperature sterile 0.9% saline.
• Durepair is for single-patient use only and is to be implanted surgically.
• Rinse surgical gloves to remove glove powder prior to touching Durepair.
• Do not use product if past the date of expiration indicated on the package label.
• Do not use if product appears to shrink significantly when hydrated.
• Animal study results suggest that the foreign body response associated with the use of sealants and hemostatic agents in conjunction with Durepair may be more pronounced than use of Durepair alone. This response may increase the incident rates of known risks of dura substitutes, particularly in high-pressure gradient applications. If intending to use ancillary products with Durepair, ensure the products are applied in accordance with their instructions for use.

Complications

General risks may include infections, CSF leaks, adhesions, hematomas, rejection/foreign body reaction, inflammatory reactions, and calcification. The patient should be made aware of these risks and others associated with neurosurgery, general surgery, and the use of anesthesia.

Important Safety Information

This therapy device is not for everyone. Please consult your physician. A prescription is required. For more information, please contact 1-800-468-9710.

For further information, please call Medtronic NT at 1-800-468-9710, or contact your Medtronic NT sales representative.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.