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Probable Benefits and Risks – Melody Transcatheter Pulmonary Valve

Humanitarian Device

Authorized by Federal law (USA) for use in pediatric and adult patients with a regurgitant or stenotic Right Ventricular Outflow Tract (RVOT) conduit (≥ 16 mm in diameter when originally implanted). The effectiveness of this device for this use has not been demonstrated.

Melody® TPV Therapy has been approved under a Humanitarian Device Exemption by the FDA. It is a revolutionary, non-surgical option for treating narrowed or leaking pulmonary valve conduits. The goal of the therapy is to restore conduit function while delaying your next open-heart surgery as long as possible.

Probable Clinical Benefits

Melody TPV Therapy does not replace open-heart surgery as a treatment for conduit failure, however it is designed to delay your next surgical intervention.

In clinical study, Melody TPV Therapy has shown the following probable clinical benefits:

Restored pulmonary valve conduit function1

  • Relief of narrowing (stenosis)
  • Relief of leaking (regurgitation)

Increased pulmonary valve conduit lifespan1

  • Delay of a patient’s next open-heart surgery

The effectiveness of this device has not been demonstrated.

Possible Adverse Events

As with any cardiac catheterization procedure, certain complications may occur. The potential risks associated with Melody TPV are similar to those if you had a cardiac catheterization procedure to have the narrowing in your homograft or conduit stretched with a balloon and/or a stent (wire frame) placed to hold the conduit open.

Cardiac catheterization has been associated with serious complications, including death. Complications that may occur from any catheterization procedure include the following:

  • Tearing of the blood vessel where the catheter is inserted
  • Bleeding from the site where the catheters are inserted
  • Irregular heart beat
  • Perforation of a heart chamber
  • Allergic reaction to the x-ray dye
  • Infection
  • Pain, swelling, and bruising at the site where the catheter was inserted
  • Fever
  • Reddening of the skin due to x-ray
  • Stroke

Other complications that may result from implantation of the Melody TPV include the following:

  • Breakage of the wire frame that supports the tissue valve
  • Ineffective function of the valve (leakage of the valve)
  • Dislodgment of the valve from where it was implanted
  • Clot formation within the valve that affects its function or travels to the lung
  • Infection of the valve (endocarditis)
  • Tearing of the conduit during the procedure
  • Blockage of arteries that supply the heart

Important Information About Stent Fracture

In some patients, the stent (wire frame) of the Melody TPV may break because of the forces it is exposed to in the body. The chance of the stent breaking may increase the longer the device is in the body. There is up to a 35 percent chance that the Melody TPV stent will break within one year of placement. In some cases, the broken stent does not require additional treatment. A doctor will determine the best treatment option.

However, a broken stent has the potential to become serious and could result in the need for another catheter intervention, an operation to replace the conduit, or could lead to death.

For the complete data set, additional information and Instructions for Use documentation, contact Medtronic LifeLine CardioVascular Technical Support at 877-526-7890.

Reference
1. Melody Transcatheter Pulmonary Valve Clinical Evidence Report. Data on file. Medtronic, Inc. 2009.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 22 Sep 2010

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