FDA Approves Smallest Heart Valve

The US Food and Drug Administration (FDA) approved the extension of Heart Valve Masters Series with Hemodynamic Plus (HP) (Abbott) sewing cuff by the size of the 15 mm valve, allowing the smallest heart valve in the world.

The FDA has granted St. Jude Medical approval for the heart valve of the Master Series.

The valve is now available in sizes between 15mm and 27mm since it has been approved larger sizes since 1995, two pyrolytic carbon brochures, an opening angle of 85 degrees, which promotes blood circulation, while reducing turbulence and providing a means to the device during the Implantation to rotate for optimal results

“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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The mechanical valve Masters Series mechanical heart was first diagnosed with a heart valve of the aorta or mitral diseased, damaged or defective, FDA approved in 1995 for patients. The smallest heart valve is also approved for the replacement of previously implanted aortic or mitral valve heart valves. “Today’s approval extends the range of valve sizes available and offers smaller patients another treatment option,” the statement said.

Heart valve disease occurs when one or more of the four heart valves that conduct blood flow through the heart do not function properly. In children, heart valve malfunction is often the result of congenital heart disease at birth. More than 35,000 babies in the US every year are born with congenital heart defects, some of which require heart valve surgery and possibly heart valve replacement surgery. However, before today’s approval, options for available replacement heart valves were limited due to the small size of the patients. The HP 15mm Masters Series Valve is an important treatment option for these patients. The Master Series mechanical heart valve should not be used by patients who can not tolerate anticoagulant therapy.

The FDA evaluated clinical data from a one-arm study in 20 pediatric patients with severe heart failure ranging from 1.5 weeks to 27 months at the time of mitral valve implantation. The data showed that one year after implantation, the survival probability of 69.3 percent and the probability of an adverse event related to the valve were 66.8 percent. The serious cardiac valve-related adverse events seen during the one year post-study study included blood clots in the device and brain hemorrhages. An anticoagulation therapy (dilution of the blood) may be required after the procedure to avoid the formation of blood clots in the device, which may increase the risk of bleeding.

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