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World's smallest mechanical heart valve scores FDA approval

por Lauren Dubinsky, Senior Reporter | March 09, 2018
Cardiology Pediatrics
St. Jude Medical's Masters HP Mechanical
Heart Valve Standard Cuff
The FDA approved the world’s smallest mechanical heart valve on Tuesday to meet the needs of young pediatric patients with congenital valve defects.

Abbott’s Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff is now available in a 15-millimeter valve size.

The FDA told HCB News that the options for patients who could not fit a larger mechanical valve were a valve taken from a human donor, porcine or bovine valve or the patient’s own pulmonary valve taken and used to replace an aortic or mitral valve.

Congenital heart defects are the most common types of birth defects, according to the Centers for Disease Control and Prevention. They affect about 40,000 births per year in the U.S.

The FDA assessed clinical data from a study of 20 pediatric patients between the age 1.5 weeks and 27 months with serious heart failure at the time of mitral valve implant. The results demonstrated that the probability of survival was 69.3 percent and probability of not experiencing a valve-related adverse event was 66.8 percent one year after implant.

The serious valve-related adverse events that were observed during the one-year follow-up period included blood clots in the devices and bleeding in the brain. Anticoagulation therapy might be necessary after the procedure to prevent clotting, and that can elevate the risk of bleeding.

The Master Series Mechanical Heart Valve is a rotatable, two-leaflet valve, designed to be implanted in the aortic or mitral position. It is composed of two semi-circular discs that open and close in response to blood pressure changes during the patient’s heartbeat.

It was first approved by the FDA in 1995 for patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. It also has approval for use in replacing previously implanted aortic or mitral prosthetic heart valves.

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