FDA approves mechanical heart valve for newborns

March 7, 2018

(HealthDay)—The U.S. Food and Drug Administration has approved the world's smallest mechanical heart valve, designed to be used in newborns and other young infants with heart defects.

In a news release Tuesday, the agency said it approved a 15-mm version of the Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff. This mechanical heart valve was first approved in 1995 for patients with diseased, damaged, or malfunctioning aortic or mitral . Approval of the smaller size valve was based on a clinical study of 20 infants ranging in age from 1.5 weeks to 27 months.

Potential valve-related adverse reactions could include blood clots in the device and bleeding in the brain. The valve should not be used in patients who cannot tolerate anticoagulation therapy, the FDA said.

"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 defects who may be too small to use currently-marketed valves," Jeff Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.

The Masters Series Mechanical Heart Valve is made by St. Jude Medical, based in St. Paul, Minn.

Explore further: Redoing heart valve replacements using a minimally invasive approach

More information: More Information

Related Stories

Redoing heart valve replacements using a minimally invasive approach

February 20, 2018
There are some instances in life where you wish you could have a redo, but surgery isn't one of them. However, if a redo is necessary, knowing that there is a minimally invasive option can be comforting. Dr. Joseph Lamelas, ...

FDA expands approval for 'valve in valve' aortic replacement

March 31, 2015
(HealthDay)—The U.S. Food and Drug Administration said Tuesday that use of the CoreValve "valve-in-valve" aortic replacement has been expanded to include people at extreme risk for serious complications of traditional ...

FDA: improved artificial heart valve approved

June 19, 2015
(HealthDay)—The newest version of the Sapien 3 Transcatheter Heart Valve has been approved by the U.S. Food and Drug Administration.

Approval expanded for sapien artificial heart valve

October 22, 2012
(HealthDay)—U.S. Food and Drug Administration approval for the Sapien Transcatheter Heart Valve has been expanded to include additional people with aortic valve stenosis, the medical term for a narrowing of the aortic valve ...

Fewer infections in mechanical heart valves

July 19, 2017
Infections in surgically implanted heart valves are more common in patients who have been given a biological prosthetic valve than in those with a mechanical one, a study from Karolinska Institutet published today in the ...

Heart valves made from tissue rather than metal may be better for middle-aged patients

January 12, 2016
Patients between the ages of 40 and 70 who undergo aortic valve replacement (AVR) may fare better with tissue-based valves rather than metal-based valves, according to a review article posted online today by The Annals of ...

Recommended for you

Noisy workplace may wreak havoc on your heart

March 22, 2018
(HealthDay)—Loud noise at work doesn't just threaten your hearing, it might also boost your blood pressure and cholesterol levels, a new U.S. government report suggests.

Smartwatch effective in detecting atrial fibrillation

March 22, 2018
Irregular heart impulses that lead to stroke can be detected with great accuracy using a smartwatch with a specially designed application, a finding that could eventually lead to new ways to screen patients for earlier treatment, ...

AI is quicker, more effective than humans in analyzing heart scans

March 22, 2018
A type of artificial intelligence known as advanced machine learning can classify essential views from heart ultrasound tests faster, more accurately and with less data than board-certified echocardiographers, according to ...

Majority of U.S. adults have poor heart health: study

March 19, 2018
(HealthDay)—America's heart health went from bad to worse between 1988 and 2014, a new report warns.

Drinking alcohol makes your heart race

March 18, 2018
The more alcohol you drink, the higher your heart rate gets, according to research presented today at EHRA 2018 Congress, organized by the European Society of Cardiology.

Study of nearly 300,000 people challenges the 'obesity paradox'

March 15, 2018
The idea that it might be possible to be overweight or obese but not at increased risk of heart disease, otherwise known as the "obesity paradox", has been challenged by a study of nearly 300,000 people published in in the ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.