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FDA Approves Medtronic's Melody Transcatheter Pulmonary Valve
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January 27, 2015 -- This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Valve Delivery System
HDE Applicant: Medtronic, Inc.
Address: 8200 Coral Sea Street NE, Mounds View, MN 55112
Approval Date: January 27, 2015
Approval Letter:

Angioplasty.Org Image

What is it? The Medtronic Melody Transcatheter Pulmonary Valve (TPV) is an artificial heart valve made from the jugular vein valve of a cow that is sewn into a small metal frame. The Medtronic Ensemble Transcatheter Valve Delivery System is a thin, hollow, and long tube (catheter) that delivers the Melody TPV into the heart without open heart surgery while the heart is beating.

How does it work? The Melody TPV is first compressed onto a balloon at the tip of the delivery catheter. Through a small incision typically in the groin, the Melody TPV is pushed through a vein to the failing pulmonary heart valve. The small balloon is then inflated to open up the Melody TPV and the catheter is removed from the body. The Melody TPV immediately becomes the new pulmonary heart valve.

When is it used? Patients born with heart defects often receive a pulmonary valve conduit (an artificial graft with a valve inside that connects the heart to the lungs) to correct the defects. Over time, the conduit may become narrowed or leaky and will need to be replaced. The Melody TPV is used to treat a failing conduit.

What will it accomplish? Patients born with heart defects typically need several surgeries during their lifetime to correct their heart problems. The use of the Melody TPV will delay the time when a patient needs additional open heart surgery. It can also reduce the total number of open heart surgeries a patient needs.

When should it not be used? There are no known contraindications for the Melody TPV. Heart doctors can help patients decide if the Melody TPV may be the right therapy for them.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Other Resources:

Source: U.S. Food and Drug Administration