PB1016

Product image of the Melody™ transcatheter pulmonary valve

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.

Not what you're looking for?

United States

Customer Care Team