About the therapy and procedure Melody Transcatheter Pulmonary Valve (TPV)

Alert Indications, Safety, and Warnings

A less-invasive approach to restore valve function

Melody™ transcatheter pulmonary valve (TPV) technology is a nonsurgical option to restore pulmonary valve function in children and adults with right ventricular outflow track (RVOT) conduit dysfunction or dysfunctional surgical bioprosthetic pulmonary valves. It allows you to deliver a replacement valve via a catheter through the body's cardiovascular system, thus eliminating the need to open the chest.

Melody TPV therapy has been proven to relieve conduit and surgical valve obstruction, restore valve function, and delay the patient’s next surgical intervention.

Most medical procedures have risks. The Melody TPV procedure's more serious risks include: valve dysfunction, stent fracture, and endocarditis.

How it works

The Melody valve is specifically designed to treat RVOT valve dysfunction. Comprised of a bovine jugular vein (BJV) valve sutured within a platinum iridium frame, the Melody valve has naturally derived venous valve leaflets which open and close under minimal pressure for optimal hemodynamics on the right side of the heart. Deep coaptation of the leaflets provides valve competency across a range of conduit sizes and geometries. The Melody valve is delivered via the Ensemble™ II delivery system, which utilizes balloon-in-balloon (BIB) technology for controlled valve deployment.

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Proven performance

Data from the US IDE Study showed strong valve performance; 97% of patients showed none/trace/mild pulmonary regurgitation 10 years after implantation. Post-implant mean gradients didn’t exceed 20 mm Hg throughout 10-year follow-up.

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Procedure steps

  1. The catheter is inserted into the patient’s vein through a small access site.
  2. The catheter holding the Melody valve is placed in the vein and guided into the patient’s heart.
  3. Once the Melody valve is in the right position, the balloons are inflated.
  4. The Melody valve expands into place, and blood will flow between the patient’s right ventricle and lungs.
  5. The catheter is removed.
  6. Fluoroscopy confirms that the Melody valve is functioning properly.
  7. The access site is closed.
Melody transcatheter pulmonary valve pictured with the Ensemble II delivery system

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