Is Melody Transcatheter Pulmonary Valve Therapy Right for You?
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® Transcatheter Pulmonary Valve (TPV) Therapy treats narrowed or leaking pulmonary valve conduits without open-heart surgery. Melody TPV Therapy is an adjunct to surgery for children and adults with Right Ventricular Outflow Tract (RVOT) conduit failure. Melody TPV Therapy is designed to prolong the life of your conduit and delay your next surgical intervention.
Melody TPV Therapy may be right for you if you have a narrowed or leaking conduit that connects the right ventricle to the pulmonary artery.
When Melody TPV Therapy Is Not an Option
There are certain conditions in which Melody TPV Therapy should not be used. Melody TPV Therapy should not be used in a patient:
- Whose conduit is too large or too small
- Whose veins are too small for the delivery system
- Who has signs of infection
Your heart doctor can help decide if Melody TPV Therapy may be right for you.
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.
