Melody® Transcatheter Pulmonary Valve
Ensemble® Transcatheter Valve Delivery System
Important Labeling Information for United States
The Melody TPV is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted AND
- Dysfunctional RVOT conduits with a clinical indication for intervention, AND:
- regurgitation: ≥ moderate regurgitation, AND/OR
- stenosis: mean RVOT gradient ≥ 35mm Hg
- 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.
*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.
For additional information, please refer to the Instructions For Use provided with the product.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.