Transcatheter valves

Melody™ transcatheter pulmonary valve

<p>The Melody™ transcatheter pulmonary valve (TPV) uses Ensemble™ II transcatheter delivery system to treat right ventricular outflow tract (RVOT) dysfunction.</p>

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Indications, Safety, and WarningsMRI Safety InformationIndications
The Melody™ transcatheter pulmonary valve is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has ≥ moderate regurgitation, and/or a mean RVOT gradient ≥ 35 mm Hg.ContraindicationsNone known.Warnings/precautions/side effects

Do not implant in the aortic or mitral position. Preclinical bench testing of the Melody™ valve suggests that valve function and durability will be extremely limited when used in these locations.

Do not use if patient’s anatomy precludes introduction of the valve, if the venous anatomy cannot accommodate a 22 Fr size introducer, or if there is significant obstruction of the central veins.

Do not use if there are clinical or biological signs of infection including active endocarditis. Standard medical and surgical care should be strongly considered in these circumstances.

Assessment of the coronary artery anatomy for the risk of coronary artery compression should be performed in all patients prior to deployment of the TPV.

To minimize the risk of conduit rupture, do not use a balloon with a diameter greater than 110% of the nominal diameter (original implant size) of the conduit for pre-dilation of the intended site of deployment, or for deployment of the TPV.

The potential for stent fracture should be considered in all patients who undergo TPV placement. Radiographic assessment of the stent with chest radiography or fluoroscopy should be included in the routine postoperative evaluation of patients who receive a TPV.

If a stent fracture is detected, continued monitoring of the stent should be performed in conjunction with clinically appropriate hemodynamic assessment. In patients with stent fracture and significant associated RVOT obstruction or regurgitation, reintervention should be considered in accordance with usual clinical practice.

Potential procedural complications that may result from implantation of the Melody™ device include the following: rupture of the RVOT conduit, compression of a coronary artery, perforation of a major blood vessel, embolization or migration of the device, perforation of a heart chamber, arrhythmias, allergic reaction to contrast media, cerebrovascular events (TIA, CVA), infection/sepsis, fever, hematoma, radiation-induced erythema, blistering, or peeling of skin, pain, swelling, or bruising at the catheterization site.Potential device-related adverse events that may occur following device implantation include the following: stent fracture^†, stent fracture resulting in recurrent obstruction, endocarditis, embolization or migration of the device, valvular dysfunction (stenosis or regurgitation), paravalvular leak, valvular thrombosis, pulmonary thromboembolism, hemolysis.For additional information, please refer to the instructions for use provided with the product or available on manuals.medtronic.com.Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.† The term "stent fracture" refers to the fracturing of the Melody™ TPV. However, in subjects with multiple stents in the RVOT it is difficult to definitively attribute stent fractures to the Melody™ frame versus another stent.Nonclinical testing and modeling have demonstrated that the Melody™ transcatheter pulmonary valve (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.

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.

Transcatheter pulmonary valve replacement procedure animation (02:31)

Product details

This is a right-facing image of the Melody™ TPV, which is indicated for CHD patients with RVOT conduit dysfunction or dysfunctional surgical bioprosthetic pulmonary valves.

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.

This is a left-facing image of the Melody™ transcatheter pulmonary valve, a nonsurgical option to restore pulmonary valve function in children and adults.

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

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