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Contegra

Pulmonary Valved Conduit

  • Contegra Pulmonary Valved Conduit

Contegra Pulmonary Valved Conduit – HDE*

The Contegra® Conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT).

Summary

A Reliable Alternative

The Contegra® Conduit is an integrated valved conduit for reconstruction or replacement of the natural right ventricular outflow tract (RVOT) or replacement of a failed homograft or composite pulmonary conduit in patients.

Natural
Derived from a bovine jugular vein, the Contegra Conduit has no discontinuity between the lumen of the conduit and the trileaflet venous valve it incorporates. It is designed to allow the passage of blood across a continuous tissue interface and natural valve sinus.

Versatile

  • The Contegra Conduit offers unique tailoring and suturing options
  • Available in both unsupported and supported models
  • Easily bent to arc onto the right ventricle
  • Thin, extensible tissue is especially suited for anastomosis to delicate tissue of the right ventricle and pulmonary arteries
  • Easily customized to individual needs
  • Proximal length allows for infundibular shaping without patching
  • Resilient wall retains suture, as well as supports hemostatic suture line
  • No additional material necessary for proximal anastomosis

Convenient
The conduit is preserved in buffered glutaraldehyde and is readily available because no thawing or preclotting is required. The conduit is rinsed per instruction using an isotonic saline solution.

Important Safety Information

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.

* Humanitarian Use Device:
Authorized by Federal law for use in patients under 19 years of age for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in the following congenital heart malformations: Pulmonary Stenosis, Tetraogy 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 dysfunctional pulmonary homografts or valved conduits. The effectiveness of this device for these uses has not been demonstrated.