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The Sulzer Carbomedics AnnuloFlex™ Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.

The Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.

The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is a gelatin-sealed, woven polyester graft. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. This gelatin has been shown to be safe and effective through PMA #P890045 on January 11, 1993.

The AnnuloFlo® System is intended for use in the repair of the human cardiac valve. The AnnuloFlo® annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

The AnnuloFlo® System consists of an annuloplasty ring, and a prosthesis of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while retaining the native valve apparatus. The AnnuloFlo® annuloplasty ring employs materials with a long and satisfactory history of use in cardiovascular applications. All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRI). The annuloplasty ring consists of a titanium stiffener ring enclosed in a sewing ring of silicone and knitted polyester fabric. The mitral AnnuloFlo® annuloplasty ring is kidney shaped. The curved posterior segment of the ring corresponds to the native posterior leaflet. The open segment of the ring corresponds to the anterior leaflet.

Sulzer Carbomedics CardioFix™ Pericardium is indicated for the following uses: • Intracardiac Repair ► Ventricular repair using a reinforced patch technique (i.e., minimum of double thickness). ► Atrial Repair. • Great vessel repair and suture line buttressing using a reinforced patch technique (i.e., minimum of double thickness) for applications exposed to peak systolic pressure. • Pericardial Closure.

The Sulzer Carbomedics CardioFix™ Pericardium is prepared from bovine pericardium stabilized using a dye-mediated process referred to as the PhotoFix® process. This 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. The CardioFix™ Pericardium is sterilized by ethylene oxide and is supplied sterile in a sealed 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 before implantation is not required. The CardioFix™ Pericardium is available in the following sizes: 1 cm x 1 cm, 4 cm, 6 cm x 8 cm, 8 cm x 14 cm, 10 cm x 16 cm, and 14 cm x 16 cm.

The AnnuloFlex annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.

The Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CPHV™ mitral valve in situ when necessary to avoid anatomical obstruction.

The sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction. The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series. The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications.

Sulzer Vascutek Fluoropassiv™ Fabric is indicated for vascular patch grafting and for intracardiac patching. The Fluoropassiv™ Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.

The Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each product line is fluoropolymer coated and gelatinsealed, knitted polyester, with a base fabric porosity of 1433 ml/cm²/min, and 3495 ml/cm²/min, respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone.