Abbott Wins FDA Approval for World’s Smallest Mechanical Heart Valve

By MedTech Intelligence Staff

The 15-mm valve size is small enough to use in newborn patients to treat heart defects.

Today FDA announced that it has expanded approval of Abbott’s Masters Series Mechanical Heart Valve to include a size small enough to treat newborns. The 15-mm Hemodynamic Plus valve provides a new treatment option for pediatric patients.

“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves.” – CDRH Director Jeff Shuren, M.D.

The mechanical heart valve, which was first approved by FDA in 1995, is intended to treat patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. The rotatable, bi-leaflet valve has two semi-circular discs that open and close as blood pressure changes during the heartbeat. It is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves.

More than 35,000 babies are born in the United States with congenital heart defects each year. With some requiring heart valve replacement, the approval of the new 15-mm size of the Master Series Mechanical Heart Valve gives these little patients the possibility of treatment.

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