FDA OK's first percutaneous heart valve
FDA OK's first percutaneous heart valve
WASHINGTON - The U.S. Food and Drug Administration says it has approved the first heart valve to be implanted through a catheter and then guided into the heart. The FDA said the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System is a new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits. Officials said the new system can delay the need for open-chest surgery. "The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radio- logical Health. "Congenital heart defects represent the number one birth defect worldwide and this approval repre- sents a new, first-of-a-kind treatment option for some of those patients." As a condition of the FDA's approval, the system's manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits, as well as to evaluate the physician speciali- zation needed to perform the implantation procedure.
WASHINGTON - The U.S. Food and Drug Administration says it has approved the first heart valve to be implanted through a catheter and then guided into the heart. The FDA said the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System is a new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits. Officials said the new system can delay the need for open-chest surgery. "The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radio- logical Health. "Congenital heart defects represent the number one birth defect worldwide and this approval repre- sents a new, first-of-a-kind treatment option for some of those patients." As a condition of the FDA's approval, the system's manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits, as well as to evaluate the physician speciali- zation needed to perform the implantation procedure.
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