Melody™ transcatheter pulmonary valve
The Melody™ transcatheter pulmonary valve (TPV) uses Ensemble™ II transcatheter delivery system to treat right ventricular outflow tract (RVOT) dysfunction.
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Overview
The Melody™ transcatheter pulmonary valve (TPV) is specifically designed to treat right ventricular outflow tract (RVOT) dysfunction in conduits and surgical bioprosthetic pulmonary valves. It is comprised of a bovine jugular vein (BJV) valve sutured within a platinum-iridium frame.
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.
Product details
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.
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
Ordering information
Melody™ transcatheter pulmonary valve
| Item number | Description |
|---|---|
|
PB1016 |
|
|
PB1018 |
|
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
Related products
1
Medtronic data on file. Bench testing may not be indicative of clinical performance.