New Humanitarian Device Approval
FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Medtronic Melody® Transcatheter Pulmonary Valve (Model PB10) and Medtronic Ensemble® Transcatheter Valve Delivery System (NU10)
Manufacturer: Medtronic Heart Valves, Inc.
Address: 1851 Deere Avenue , Santa Ana, California 92705
Approval Date: 25 January 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf8/H080002a.pdf
What is it?
The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. The Melody valve is made from a cow’s jugular vein valve that is sewn into a small metal stent (scaffolding). The Melody valve comes in sizes 18, 20, and 22mm diameters and has a stent length of 28mm. The Medtronic Ensemble® Transcatheter Valve Delivery System is a catheter (long tube with small diameter) that helps guide the Melody into the heart. The Ensemble delivery system has catheters with balloon sizes of 18, 20, and 22mm.
How does it work?
The Melody heart valve is first crimped down onto the Ensemble delivery catheter’s balloon and then is fished through a vein in the groin and into the right side of the heart where it is placed into position within the pulmonary valve. The small balloon is then inflated to open up the Melody valve into position, the catheter is removed from the body, and the Melody immediately becomes the new pulmonary valve.
When is it used?
The Melody is used to repair a stenosed (blocked) or regurgitant (leaky) pulmonary heart valve that has previously been replaced to correct congenital (birth) heart defects. The Melody is put in place without using open heart surgery and while the heart is beating.
What will it accomplish?
The Melody will replace a poorly functioning, previously replaced pulmonary valve in children and adults who might otherwise need multiple open heart surgeries in their lifetime. The Melody will repair pulmonary valve function without open heart surgery and may lengthen the time until a patient needs additional open heart surgery.
When should it not be used?
This valve should not be placed into the aortic or mitral heart valve positions or if the heart has an infection.