(RxWiki News) The US Food and Drug Administration (FDA) has expanded the approval of a mechanical heart valve to include a smaller size for use in newborns.
In fact, this device — the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff — is now the smallest mechanical heart valve in the world, according to the FDA.
“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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release.
In the United States, around 35,000 babies are born with heart defects each year. Some of these defects will require valve surgery. The FDA noted that there were limited heart valve replacement options for newborn patients because of their small size.
The Masters Series Mechanical Heart Valve adds another option. Although the device has been approved since 1995, the FDA's expanded approval broadens the range of valve sizes available to patients. The FDA based this expanded approval on a study of 20 pediatric patients with serious heart failure.
Patients who are unable to tolerate anticoagulation therapy should not use this device, the FDA noted.
The FDA approved the Masters Series Heart Valve for St. Jude Medical.