DEVICE DESCRIPTION
ProPatch^® Soft Tissue Repair Matrix is a surgical mesh manufactured from bovine pericardium and treated with the SynerGraft^® decellularization process. Decellularized tissues then undergo chemical microbial and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.

ProPatch Soft Tissue Repair Matrix is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.

APPLICATIONS
ProPatch^® is intended to be used for implantation to reinforce soft tissues where weakness exists, including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.

Specific to orthopedic surgical repairs, the device is intended for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery, including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

PRODUCT SAFETY
The bovine pericardium used in the manufacture of ProPatch Soft Tissue Repair Matrix is recovered, handled, and processed in accordance with US requirements for medical devices containing materials derived from animal sources. During processing and prior to distribution, the tissues undergo validated sterilization and viral inactivation processes to ensure freedom from transmissible diseases.

Primary Product Characteristics

• Ready to use
• Multiple pre-shaped sizes
• Easily shaped to desired configuration
• Strong and flexible
• High suture retention strength
• Physical support for repair and biological scaffold for healing
• Sterile and non-pyrogenic
• Room temperature storage