This article is more than 5 years old. Information may no longer be current.
FDA grants conditional approval for Melody Transcatheter Pulmonary Valve
Click Here to Manage Email Alerts
The FDA has approved Medtronic’s Melody Transcatheter Pulmonary Valve using the Humanitarian Device Exemption, making it the agency’s first approval of a percutaneous transcatheter heart valve.
Qualifying devices are intended for use in fewer than 4,000 patients each year. The valve was designed for use in both children and adults born with a malformation of their pulmonary valve and can be delivered via catheter.
Findings from clinical studies involving 99 U.S. patients and 68 European patients suggested that the device improved heart function and clinical symptoms in the majority of those who received it, according to a press release. But despite the improvements, officials are concerned about the device’s limited durability compared with existing alternative treatments such as bare metal stents.
As a condition of approval, Medtronic will conduct two post-approval studies to assess long-term risks and safety and will also maintain a database of patients implanted with the valve. One study will include 150 patients from the initial clinical trial and will follow their progress for five years. The second study will assess the device training program and will enroll an additional 100 patients to be followed up to five years.
“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition,” Jeffrey Shuren, JD, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kin treatment option for some of those patients.”
The Melody valve was the first transcatheter valve to receive regulatory approval anywhere in the world when it received the CE Mark in Europe in 2006.