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New Humanitarian Device Approval

Contegra® Pulmonary Valved Conduit, Models 200 (unsupported) and 200S (supported) - H020003

FDA approved this device under the Humanitarian Device Exemption (HDE) program http://www.fda.gov/cdrh/ode/hdeinfo.html. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Contegra® Pulmonary Valved Conduit, Models 200 (unsupported) and 200S (supported)
Manufacturer: Medtronic Heart Valves
Address: 1851 E. Deere Ave., Santa Ana, CA 92705
Approval Date: November 21, 2003
Approval Letter: http://www.fda.gov/cdrh/pdf2/H020003a.pdf

What is it? The Contegra® Pulmonary Valved Conduit is a bioprosthetic (prosthesis made from biological material) heart valve made from a segment of cow (bovine) jugular vein. It is treated with preservatives to keep it durable, flexible, and sterilized for human implantation. The vein contains a venous valve with three leaflets (trileaflet) that open to allow the forward flow of blood and close to prevent the backward flow of blood.

At the time of implantation, the surgeon removes the patient’s defective pulmonary valve and artery and replaces them with the valved conduit.

How does it work? The Contegra Pulmonary Valved Conduit functions like the patient’s natural pulmonary valve. Three leaflets flap open to permit blood flow from the right ventricle into the pulmonary artery and then to the lungs. In conjunction with the three other heart valves (tricuspid, aortic, and mitral), this device controls the direction of blood flow through the chambers of the heart. The conduit portion of the device allows for the replacement of part of the patient’s own pulmonary artery, as needed.

When is it used? The Contegra® Pulmonary Valved Conduit can be used in children and young adults under the age of 18. The device is used to correct or reconstruct the outflow of the right ventricle in the following congenital heart malformations:

• Pulmonary stenosis: narrowing of the pulmonary valve;
• Tetralogy of Fallot: abnormal origin of the aorta from both ventricles, a hole in the wall separating the right and left ventricles, obstructed blood flow to the lungs, and thickening of the right ventricular wall;
• Truncus arteriosus: one heart artery forms both the aorta and pulmonary artery;
• Transposition with ventricular septal defect (VSD): the aorta abnormally originates from the right ventricle and the pulmonary artery abnormally originates from the left ventricle, and there is a hole in the wall separating the right and left ventricles; and
• Pulmonary artresia: complete absence of the pulmonary valve

The device is also used for:

• Replacement of previously implanted but dysfunctional pulmonary homografts (valves from human cadavers) or valved conduits.

What will it accomplish? A patient who has a diseased, damaged, or malfunctioning heart valve may feel weak, tired, or otherwise handicapped. Surgical replacement of the affected valve may be an effective option to improve the patient’s medical condition and quality of life.

When should it not be used? There are no known contraindications for this device.

Additional information: SSPB and Labeling is available at: http://www.fda.gov/cdrh/ode/h020003sum.html

Other:

• An illustrated description of the normal heart and how it works: http://www.americanheart.org/presenter.jhtml?identifier=770
• A description of heart valve anatomy and treatments for defective valve: http://www.americanheart.org/presenter.jhtml?identifier=4598
• Illustrated information on aortic valve disease and treatment:
  http://circ.ahajournals.org/cgi/content/full/106/7/770

Updated January 27, 2004

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