Transcatheter valves

Melody™ transcatheter pulmonary valve

<p>The Melody™ transcatheter pulmonary valve (TPV) uses Ensemble™ II transcatheter delivery system to treat right ventricular outflow tract (RVOT) dysfunction.</p>

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Features

A less-invasive approach to restore valve function

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

Transcatheter pulmonary valve replacement procedure animation (02:31)

Product details

This is a right-facing image of the Melody™ TPV, which is indicated for CHD patients with RVOT conduit dysfunction or dysfunctional surgical bioprosthetic pulmonary valves.

A valve specifically designed for a pulmonic indication

The Melody™ TPV was the first transcatheter valve commercially approved. Since 2006, it has benefited more than 18,000+ patients globally. TPV replacement with the Melody™ valve has proven to be a safe and effective treatment for patients with RVOT conduit or surgical valve dysfunction.

The Melody™ TPV is a less invasive approach that has been proven to:

  • Relieve conduit and surgical valve obstruction
  • Restore valve function
  • 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.

Optimal hemodynamics for the RVOT

Comprised of a BJV valve sutured within a platinum-iridium frame, the Melody™ valve is specifically designed to treat RVOT valve dysfunction and delivers consistent outcomes with excellent performance at more than 10 years of patient follow-up.

  • Natural thin leaflets open and close under minimal pressure for optimal hemodynamics in the low pressure RVOT.
  • Deep coaptation of leaflets provides valve competency across a range of conduit sizes and geometries, including noncircular environments.
  • Radiopaque stent allows for easy visualization.

 

 

This is a left-facing image of the Melody™ transcatheter pulmonary valve, a nonsurgical option to restore pulmonary valve function in children and adults.

Exceptional deliverability and ease of use

The Ensemble™ II transcatheter delivery system is designed for controlled, stepwise deployment of the valve with balloon-in-balloon technology.

Ensemble™ II features 

  • Simple hand crimping and loading 
  • Balloon marker bands aid in visualization of valve position prior to unsheathing and during deployment 
  • Integrated sheath eliminates need for additional sheath and protects valve during delivery 
  • Flexible 16 Fr shaft with true 22 Fr outer diameter profile
The Melody™ transcatheter pulmonary valve (TPV) and Ensemble™ II delivery system is a nonsurgical option to restore pulmonary valve function in children and adults with post-operative right ventricular outflow track conduit dysfunction or dysfunctional surgical bioprosthetic pulmonary valves.

Ordering information

Melody™ transcatheter pulmonary valve

Item number Description
PB1016
  • A BJV valve sutured within a platinum-iridium frame
  • Melody™ TPV 20
  • 16 mm BJV valve
  • Acceptable deployment: up to an inner diameter of 20 mm
PB1018
  • A BJV valve sutured within a platinum-iridium frame
  • Melody™ TPV 22
  • 18 mm BJV valve
  • Acceptable deployment: up to an inner diameter of 22 mm

Note: To facilitate manufacturing (sewing of the tissue onto the TPV frame), the initial out-of-the-jar lengths of the two valves will differ slightly (30 mm length for PB1016 and 28 mm length for PB1018). Once crimped on the delivery system, the lengths of both TPV sizes will be the same and will remain so during deployment to any size.

Ensemble™ II transcatheter delivery system

Item number Balloon size (mm) French size (Fr) Overall length (cm)
ENS1018 18 22 100
ENS1020 20 22 100
ENS1022 22 22 100
  • Ensemble™ II is a balloon-in-balloon catheter delivery system with a retractable polytetrafluoroethylene (PTFE) sheath covering.
  • Nylon inner and outer balloons are available in three sizes: 18 mm, 20 mm, and 22 mm. At inflation, the inner balloon is half the diameter of the outer balloon.
  • The sheath has a side port for flushing the system and a hemostatic sleeve to minimize bleeding at the insertion site.
  • Choose delivery system and valve size based on prepared conduit based on prepared landing zone of conduit or BPV inside diameter and intended final implant size. Valve performance for both sizes is comparable, per bench testing data.1

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  1. Medtronic data on file. Bench testing may not be indicative of clinical performance.