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The Glycar Pericardial Patch and Glycar Vascular Patch of the Glycar Tissue Repair Patch line of products are intended for pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.

The Glycar Vascular Repair Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium.

The Glycar Pericardial Patch and Glycar Vascular Patch of the Glycar Tissue Repair Patch line of products are intended for pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.

The Glycar Pericardial Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium.

The Glycar Inc., Tissue Repair Patch family of products have the same intended uses as the predicate device, the Bio-Vascular Inc., Peri-Guard™ family of products, which are all tissue patches made from the same glutaraldehyde-treated bovine pericardium. Already approved intended uses for the Glycar Tissue Repair Patch family of glutaraldehyde-tanned bovine pericardial tissue patches: The Glycar Tissue Repair Patch (K942911) was deemed substantially equivalent to the Peri-Guard™ bovine pericardial tissue patch and received approval for U.S. marketing for the intended use of hernia and other intraabdominal soft tissue defect or deficiency repair in December, 1994. An addition to the Glycar Tissue Repair Patch family of products, the Glycar Staple Strip (K954665) was deemed substantially equivalent to the Peri-Strips™ bovine pericardial surgical staple bolsters and received approval for U.S. marketing for the intended uses of surgical stapling of lung tissue, gastric staplings, rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias or defects of the diaphragm, thoracic and abdominal wall in October, 1995. The Glycar Staple Strip uses the identical material as the Glycar Tissue Repair Patch with the addition of a synthetic suture material to assist placement of the device on the surgical stapling arm.

The Glycar Tissue Repair Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium. Glutaraldehyde-treated bovine pericardium is a strong, pliable, biocompatible material which is easy to handle surgically. Glycar's glutaraldehyde-treated pericardium possesses tissue strength equaling that of the predicate device. It provides for a durable repair, replacement or reinforcement of natural soft tissue. The manufacturing process for the Glycar Tissue Repair Patches involves the harvesting of bovine pericardium, fixation of the pericardium in glutaraldehyde, inspection and cleaning of the pericardium, selection of the pericardium for use in strip production, additional tanning of the bovine pericardium, and then cutting of the glutaraldehyde-treated bovine pericardium for the designated strip size, followed by sterilization in formaldehyde, followed then by treatment with Glycar's proprietary anti-inflammation treatment, XX. Sterility is maintained by using aseptic fill under Clean Room 100 conditions, during transfer to antiinflammation treatment and to the final storage medium, 2% propylene oxide in water. Sizes and shapes will be specific for product line reflecting different indications as appropriate for the use.