First percutaneous heart valve has been approved by the US FDA

摘要

The FDA's approval is conditional upon agreement by Medtronic Inc. to carry out two post-approval studies that will assess the long-term risks and benefits as well as determining the physician specialization required to conduct the implantation procedure. Medtronic will also maintain a database of Melody recipients."The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," noted Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health."Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients."