What Is Transcatheter Pulmonary Valve Therapy?
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.
Transcatheter pulmonary valve therapy treats narrowed or leaking pulmonary valve conduits without open-heart surgery. The goal of the therapy is to restore pulmonary valve function while delaying your next open-heart surgery as long as possible.
With transcatheter pulmonary valve therapy, a catheter (a thin, hollow tube) holding an artificial heart valve is inserted into a vein in your leg and guided up to your heart. The heart valve is attached to a wire frame that expands with the help of balloons to deliver the valve. Once the new heart valve is in position, it begins to work immediately.
Melody® TPV Therapy received humanitarian device exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) in 2010.
Because of the HDE status, the Melody TPV must be implanted by a physician trained in the Melody TPV implant procedure and in a medical center whose institutional review board (IRB) has approved use of the device.
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.
- Print Page
- E-mail Page
- A
- A
- A Text Size
