Release date: 2010-03-03
Recently, the US Food and Drug Administration (FDA) approved the sale of Medtronic Melody's transcatheter pulmonary valve and Ensemble injection system, the first heart valve transplanted from the leg blood vessels through the catheter.
Pulmonary valves in patients with congenital cardiac septal defect have varying degrees of stenosis, defects or defects, which impede the supply of blood to the pulmonary artery from the right ventricle, thereby affecting the oxygenation of blood in the lungs. The disease can be treated by surgically placing a catheter for valvular transplantation.
“The FDA approved the listing of Melody, providing an invasive treatment for patients with congenital heart disease,†said Dr. Jeffrey Shuren, head of the FDA Center for Equipment and Radiation Health.
Melody's replacement does not require a thoracotomy because Melody's tissue valve maintains normal blood flow by propping up a failed catheter. This feature can extend the life of the catheter in the patient's body, thereby extending the interval between invasive thoracotomy.
Clinical studies have shown that this device can improve the patient's heart function. As an FDA-approved condition, the company will also conduct two post-approval studies to assess the long-term risks and usefulness of the system, as well as evaluate physician specialization issues for implant operations.
(Source: Kexun)
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