Heart Valve Replacement (Transcatheter)
Transcatheter valve technology represents a less invasive means for treating heart valve disease and is designed to allow physicians to deliver replacement valves via a catheter through the body's cardiovascular system, thus eliminating the need to open the chest.
CoreValve Transcatheter Aortic Valve
The CoreValve transcatheter aortic valve (TAVR) platform was designed specifically to meet the clinical needs of patients with severe aortic stenosis at extreme or high risk for surgical valve replacement.
The valve provides controlled and accurate deployment with a self-expanding Nitinol frame, optimizes hemodynamics with supra-annular valve design, and minimizes paravalvular leak with a conforming frame and sealing skirt. CoreValve is delivered through a low 18Fr delivery profile (all valve sizes) and treats an annulus range from 18-29mm.
In a randomized controlled trial comparing CoreValve TAVR to surgical valve replacement in 795 high risk patients, CoreValve survival was shown to significantly outperform surgery at one year.
For more information, visit www.corevalve.com.
Melody Transcatheter Pulmonary Valve Therapy
An Evolutionary Step in Treating Congenital Heart Disease
With more than 30 years of expertise in advanced valve therapies, Medtronic is committed to partnering with leading congenital interventional cardiologists and cardiac surgeons to develop new technologies for treating patients with congenital heart disease.
The Melody® Transcatheter Pulmonary Valve Therapy system provides a non-surgical alternative to restore effective RVOT conduit function and prolong the functional life of prosthetic conduits, thereby delaying the patient’s next surgical intervention.
Melody TPV Therapy does not replace open-heart surgery as a treatment for conduit failure, however it is intended to delay the need for surgical intervention.
Important Safety Information
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, pain at the catheterization site.
Potential device-related adverse events that may occur following device implantation include the following: 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 this product.
Humanitarian Device. Authorized by Federal law (USA) for use in pediatric and adult patients with regurgitant or stenotic Right Ventricular Outflow Tract (RVOT) conduit (>16 mm in diameter when orginally implanted). The effectiveness of this device for this use has not been demonstrated.