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Pulmonary Valved Conduit

Indications, Safety, and Warnings

Contegra Pulmonary Valved Conduit

Indications: See *Humanitarian Use Device section below.

Contraindications: None known.

Warnings/Precautions/Side Effects: Acceptable clinical performance has been established for the Contegra conduit in pediatric patients under the age of 10. Because of the possibility that complications of the device could become apparent only after extended use, a benefit-risk consideration of the long-term use of the Contegra conduit in pediatric patients over 10 years of age is particularly important. General complications reported with valved conduits and biological tissue valves implanted in the heart include: hemorrhage, bleeding diathesis due to use of anticoagulants, residual or increasing transvalvular gradients, progressive neointimal thickening and peeling, progressive stenosis and obstruction, progressive pulmonary hypertension, graft infection, endocarditis, regurgitation, hemolysis, valve malfunction, physical or chemical deterioration, thromboembolism, thrombus, conduit dilatation.

For additional information, please refer to the Instructions For Use provided with the product.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

*Humanitarian Use Device:
Authorized by Federal law for use in patients under 18 years of age for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in the following congenital heart malformations: Pulmonary Stenosis, Tetralogy of Fallot, Truncus Arteriosus, Transposition with Ventricular Septal Defect (VSD), Pulmonary Atresia. In addition, the Contegra Pulmonary Valved Conduit is indicated for the replacement of previously implanted but dysfunctional pulmonary homografts or valved conduits. The effectiveness of this device for these uses has not been demonstrated.