Melody™ TPV system for transcatheter pulmonary valve (TPV) replacement
The Melody™ transcatheter pulmonary valve (TPV) is specifically designed to treat right ventricular outflow tract (RVOT) dysfunction in conduits and dysfunctional bioprosthetic pulmonary valves. It is comprised of a bovine jugular vein (BJV) valve sutured within a platinum-iridium frame.
The Ensemble™ II transcatheter delivery system is designed for controlled, stepwise deployment of the valve with balloon-in-balloon technology.
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Overview
A valve specifically designed for a pulmonic indication
The Melody transcatheter pulmonary valve (TPV) was the first transcatheter valve commercially approved. Since 2006, it has benefited more than 17,000 patients globally. TPV replacement with the Melody valve has proven to be a safe and effective treatment for patients with right ventricular outflow tract (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
Indications
The Melody TPV is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional RVOT conduit or surgical bioprosthetic pulmonary valve that has ≥ moderate regurgitation, and/or a mean RVOT gradient ≥ 35 mm Hg.
Product details
Optimal hemodynamics for the RVOT
Comprised of a bovine jugular vein (BJV) valve sutured within a platinum-iridium frame, the Melody valve is specifically designed to treat RVOT valve dysfunction.
- 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.
- Consistent outcomes with excellent performance at more than 10 years of patient follow-up.
Most medical procedures have risks. The Melody TPV procedure's more serious risks include: valve dysfunction, stent fracture, and endocarditis.
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.
- 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.
MRI safety information
Nonclinical testing and modeling have demonstrated that the Melody TPV is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5 T and 3 T
- Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning (normal operating mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the Melody TPV is expected to produce a maximum in vivo temperature rise of less than 2.1°C after 15 minutes of continuous scanning.
MR image quality may be compromised if the area of interest is in the same area, or relatively close to the position of the device. In nonclinical testing, the image artifact caused by the device extends approximately 3 mm from the Melody TPV when imaged with a spin echo pulse sequence and 6 mm when imaged with a gradient echo pulse sequence and a 3T MRI system. The lumen of the device was obscured.
Scanning under the conditions defined above may be performed after implantation.
The presence of other implants or medical circumstances of the patient may require lower limits on some or all of the above parameters.
Manuals and technical guides
Access instructions for use and other manuals in the Medtronic Manual Library. Search by the product name (e.g., Melody) or model number (e.g., PB1016 or PB1018). You may also call 800-961-9055 for a copy of a manual.
Model specifications
Melody transcatheter pulmonary valve
| Product order number | Description A BJV valve sutured within a platinum-iridium frame |
|---|---|
| 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
| Product order number | Balloon size | French size | Overall length |
|---|---|---|---|
| ENS1018 | 18 mm | 22 Fr | 100 cm |
| ENS1020 | 20 mm | 22 Fr | 100 cm |
| ENS1022 | 22 mm | 22 Fr | 100 cm |
|
|||
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
Deployment specifications
Sizing information
| Delivery system size: |
Corresponding (balloon inflated) |
Deployed length (after balloon deflated) |
Inner balloon maximum applied pressure (RBP) |
Outer balloon applied pressure (RBP) |
||
|---|---|---|---|---|---|---|
| mm | mm | atm | kPA | atm | kPa | |
| Size 18 mm 9 mm x 3.5 cm/18 mm x 4 cm |
20.1 | 26 | 5 | 506 | 4 | 405 |
| Size 20 mm 10 mm x 3.5 cm/20 mm x 4 cm |
22.4 | 24 | 5 | 506 | 4 | 405 |
| Size 22 mm 11 mm x 3.5 cm/22 mm x 4 cm |
24.1 | 21 | 4.5 | 456 | 3 | 304 |
BJV = bovine jugular vein | RBP = rated burst pressure = maximum applied pressure | atm = atmosphere | kPa = kilopascal
Please see the product manual for complete, detailed product information.
Additional resources
Congenital heart disease (CHD) communications
Get the latest updates from the congenital heart disease (CHD) team at Medtronic.
Contact us
LifeLine cardiovascular technical support
877-526-7890
Reference
1
Medtronic bench testing data on file.