Healthcare Professionals
Melody™ TPV / Ensemble™ II Delivery System
Transcatheter Pulmonary Valve (TPV) Replacement
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Healthcare Professionals
Melody™ TPV / Ensemble™ II Delivery System
Transcatheter Pulmonary Valve (TPV) Replacement
The Melody transcatheter pulmonary valve (TPV) was the first transcatheter valve commercially approved. Since 2006, it has benefited more than 15,000 patients globally. TPV replacement with the Melody valve has proven to be a safe and effective treatment for patients with post-operative right ventricular outflow tract (RVOT) conduit or surgical valve dysfunction.
The Melody TPV is a less-invasive approach that has been proven to:
The Melody™ TPV is indicated for use in patients with the following conditions:
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.
The Ensemble II transcatheter delivery system is designed for controlled, stepwise deployment of the valve with balloon-in-balloon technology.
Nonclinical testing and modeling has 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:
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 3 T 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.
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).
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.
Product Order Number | Balloon Size | French Size | Overall Length |
---|---|---|---|
ENS1018 | 18 mm | 22 | 100 cm |
ENS1020 | 20 mm | 22 | 100 cm |
ENS1022 | 22 mm | 22 | 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
Delivery System Size Inner Balloon / Outer Balloon |
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 product manual for complete, detailed product information.
Medtronic bench testing data on file:
U.S. Investigational Device Exemption Study (IDE)
U.S. Post-approval Study (PAS)
EU/CA Post-market Surveillance Study (PMSS)