The US Food and Drug Administration (FDA) expanded approval of the Masters Series Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (St Jude Medical) to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
Until now, pediatric patients have had limited replacement heart valve options because of their small size. The Masters Series 15-mm HP valve represents an important treatment option for these patients, the FDA said in a statement.
“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 Jeff Shuren, MD, director, FDA Center for Devices and Radiological Health.
The product is a rotatable, bileaflet valve designed for implantation in the aortic or mitral position. It consists of two semi-circular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve.
The Masters Series Mechanical Heart Valve was first approved in 1995 for patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve, the FDA notes. The device is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves. “Today’s approval expands the range of valve sizes available, providing smaller patients another treatment option,” the statement said.
For the expanded approval, the FDA reviewed clinical data from a single-arm study of 20 pediatric patients with serious heart failure who were aged 1.5 weeks to 27 months at the time of mitral valve implant.
One year after the implant procedure, the probability of survival was 69.3% and the probability of not experiencing a valve-related adverse event was 66.8%.
Serious valve-related adverse events observed during the study through 1-year follow-up included blood clots in the device and brain hemorrhage. Anticoagulation therapy may be necessary after the procedure to prevent clotting on the device, which can increase the risk for bleeding, and the device should not be used in patients who cannot tolerate anticoagulation therapy, the FDA said.
Each year, more than 35,000 babies in the United States are born with congenital heart defects, some of which will require heart valve surgery and, potentially, replacement heart valve surgery, the FDA notes.
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