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Clinical evidence

Melody™ transcatheter pulmonary valve

Twelve years of evidence points to Melody™ transcatheter pulmonary valve (TPV) as the right choice, for the right patient.

Indications, Safety, and WarningsIndications
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.

Durability

Stability

Endocarditis

Resources

Explore long-term
patient outcomes.

Prof Peter Ewert, M.D., shares his perspectives about the Melody™ TPV and its positive impact on patients treated with this life-changing therapy.

Exceptional durability

Demonstrates survival without reoperation¹
Compares favorably to surgery¹

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Stable valve hemodynamics

Helps delay surgical intervention in the majority of patients¹

Consistent long-term stable valve function through 12 years (mean RVOT gradient < 20 mmHg)¹

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Mitigates risk

Yields excellent outcomes long term²

Conduit preparation and ensuring minimal residual pressure gradient prior to PVI can reduce the risk of infective endocarditis.²

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Important safety information

Most medical procedures have risks. The Melody™ TPV procedure’s more serious risks include valve dysfunction, stent fracture, and endocarditis.

Resources

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Melody™ TPV 12-year Clinical Evidence Brochure - U.S. (open in new window)

Download this brochure to read about 12-year clinical evidence for the Melody™ transcatheter pulmonary valve (TPV).

CLINICAL EVIDENCE PDF 1 MB

Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up. Circ Cardiovasc Interv. July 2020;13(7):e008963.
Georgiev S, Ewert P, Tanase D, et al. A low residual pressure gradient yields excellent long-term outcome after percutaneous pulmonary valve implantation. JACC Cardiovasc Interv. August 26, 2019;12(16):1594-1603.

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