Catheter-Based Heart Valve Approved in US
The valve was developed by Medtronic Inc. It was designed to be implanted using a catheter that will be inserted into the body. It will go through a leg vain and will be guided to the heart. It will be known as Melody Transcatheter Pulmonary Valve.
The heart valve device “allows patients to undergo a much less-invasive procedure to treat their heart condition,” said Jeffrey Shuren, director of the FDA’s Devices Division.
It was approved via the FDA’s Humanitarian Device Exemption Program since the approach used for the device was designed to help patients with previously implanted but poorly pulmonary valve conduits. The conduits, and the valve, help treat patients with congenital heart defects that disrupt the blood flow from the heart’s right ventricle to the pulmonary artery which leads to the lungs.