Contegra

Indications, Safety, and Warnings

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: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.