Heart Valve Inserted Through Leg Approved by FDA

28 January 2010 (Last Updated January 28th, 2010 18:30)

The first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart has received approval from the US Food and Drug Administration (FDA). The Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, approved under the Humanitarian Device

The first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart has received approval from the US Food and Drug Administration (FDA).

The Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, approved under the Humanitarian Device Exemption (HDE) programme, is intended to provide another option to surgically implanted valves used to treat congenital heart defects of the pulmonary valve.

This new way of treatment for adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

The Melody valve is advantageous to paediatric patients with right-sided valvular heart disease who may face several surgeries over their lifetimes.

The FDA's Center for Devices and Radiological Health director Jeffrey Shuren said that Melody allows patients to undergo a much less invasive procedure to treat their heart condition.

"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," Shuren said.

As a condition of the FDA's approval, the system's manufacturer, Medtronic of Minneapolis, will conduct two post-approval studies over five years enrolling 250 participants to assess long-term risks and benefits.