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PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.

PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.

PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, suture line buttressing and pericardial closure. PhotoFix® Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch prepared from bovine pericardium which is stabilized using a dye-mediated photooxidation process, processed using ethylene oxide and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed plastic container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium prior to implantation is not required.

PerClot Topical is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of mildly bleeding wounds such as surgical wounds (postoperative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.

PerClot® Topical is a medical device composed of absorbable polysaccharide granules and delivery applicators. The granules are biocompatible, non-pyrogenic and derived from purified potato starch. The granules do not contain any human or animal components. PerClot granules have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding and results in the concentration of platelets, red blood cells, and coagulation proteins (thrombin, fibrinogen, etc.) at the site of application. The gelled adhesive matrix thus promotes the normal physiological clotting cascade. PerClot granules are enzymatically degraded by alpha-amylase and glucoamylase and by macrophages.

ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. ProPatch® is indicated for the reinforcement, where weakness exists, of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadricens, or other tendons.

ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from bovine pericardium. Decellularized tissues undergo chemical microbial reduction and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation. ProPatch is comprised of a single tissue 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.

ProPatch® is indicated 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. ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Non-Joint Related Repair ProPatch is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. Joint Related Repair ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation. ProPatch 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.

CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.

The Cryor atch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period, harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing cryoprotectants, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C. CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch. Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.

CryoValve® SG Pulmonary Human Heart Valve (and Conduit) are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve (CryoValve SG) is a human heart valve aseptically recovered from qualified donors. The valve is dissected, treated with an antimicrobial solution, and treated to remove the cells and cellular debris that has not already been removed during the postmonten, and harvesting, and the antimicrobial process. The valve is cryopreserved in a tissue culture medium, cretaining a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system nonly withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating room, Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valves are transferred to a liquid nitrogen freezer for long-term storage at -135°C to -196°C.

CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.

The CryoPatch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period. harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C. CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch. Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.

CryoValve® SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosihetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

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