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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Melody transcatheter pulmonary valve (TPV) with Ensemble II delivery system on white background

Alert Indications, Safety, and Warnings

Overview

Melody transcatheter pulmonary valve (TPV) right-facing

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.

Melody transcatheter pulmonary valve (TPV) left-facing with leaflets

INDICATIONS

The Melody™ TPV is indicated for use in patients with the following conditions:

Patients with regurgitant prosthetic right ventricular outflow tract (RVOT) conduits or bioprostheses with a clinical indication for invasive or surgical intervention; OR
Patients with stenotic prosthetic RVOT conduits or bioprostheses where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting

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.

Melody transcatheter pulmonary valve (TPV) with Ensemble II delivery system shown horizontally on white background

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).

Model specifications

Melody™ transcatheter pulmonary valve

Ensemble II Delivery System: 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 visualisation 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

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).

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

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
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. Sheath with 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

Deployment specifications

Sizing information

Delivery system size: inner balloon/outer balloon	Corresponding valve outside diameter (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

Clinician resources

Congenital heart disease (CHD) communications

Get the latest updates from the congenital heart disease (CHD) team at Medtronic.

Reference

Medtronic bench testing data on file.