Healthcare Professionals

Melody™ TPV / Ensemble™ II Delivery System

Transcatheter Pulmonary Valve (TPV) Replacement

  • Melody TPV Ensemble II Transcatheter Pulmonary Valve System

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 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:

  • 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 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

PRODUCT DETAILS 

Melody Valve: 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 non-circular environments.
  • Radiopaque stent allows for visualisation ease.
  • Consistent outcomes with excellent performance at more than 7 years of patient follow-up.
Melody TPV - Optimal Hemodynamics for the RVOT
Melody TPV - Exceptional Deliverability and Ease of Use
Melody TPV Ensemble II Transcatheter Pulmonary Valve System

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

Magnetic Resonance Imaging (MRI) Safety Information

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:

  • 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 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.

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

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 22 100 cm
ENS1020 20 mm 22 100 cm
ENS1022 22 mm 22 100 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 minimise 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 product manual for complete, detailed product information.

1

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)