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The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.

PeriBeam® is an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) membrane used for reconstruction or repair of the pericardium. This device is intended for use as a temporary or permanent prosthesis for repair of pericardium

Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated. Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.

The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation. Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses. The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.

The ADAPT® Tissue is indicated for use as a patch in the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair.

The ADAPT® Tissue medical device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. The products range in size from 4cm² to 84cm² and can range in thickness from 0.25-0.80mm.

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.

VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.

The VascuCel device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. It is offered in a 2 x 8 cm size and a 0.8 x 8 cm size.

The CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defect and annulus repair, suture-line buttressing, and cardiac repair.

CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair. CorMatrix® Tyke™ is derived from the same multi-laminate SIS-ECM material as the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix® Tyke™ will be supplied as a 2-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts, the device design and construction are identical to the FDA-cleared CorMatrix ECM for Cardiac Tissue Repair (K063349).

PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas, when a non-absorbable suture is indicated. Pledgets are also used to aid in suture buttressing.

The PremiPatch PTFE Pledgets are pre-cut sections of non-absorbable undyed polytetrafluorothylene (PTFE) which are supplied sterile. The PremiPatch PTFE Pledgets are used as a suture buttress for nonabsorbable sutures. The pledgets are available in two application styles: firm and soft and various shapes and sizes. Depending on the size they are available package two or six per pouch.

SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure. PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

SUPPLE PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. SUPPLE PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation. SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. PERI-GUARD is terminally sterilized using gamma irradiation. PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. VASCU-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. VASCU-GUARD is terminally sterilized using gamma irradiation. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

The CorMatrix® ECM® for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

The CorMatrix ECM for Vascular Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). The device is constructed of a multilaminate (6-ply), decellularized, non-crosslinked, lyophilized ECM cut to specific shapes and sizes and terminally sterilized using Ethylene Oxide gas. The 6-ply CorMatrix ECM for Vascular Repair is derived from the same multilaminate SIS-ECM material as the CorMatrix ECM for Carotid Repair (6-ply), the Cook Biotech Surgisis Peripheral Vascular Patch (4-ply), and the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix ECM for Vascular Repair will be supplied as a 6-ply, lyophilized, sterilized sheet of SIS-ECM. The device design, construction, and configurations are identical to the FDA-cleared CorMatrix ECM for Carotid Repair (K111187).