Navigation Links
FDA Approves Mechanical Cardiac Assist Device for Children With Heart Failure
Date:12/16/2011

SILVER SPRING, Md., Dec. 16, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.

"This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," said Susan Cummins, M.D., M.P.H., chief pediatric medical officer in the FDA's Center for Devices and Radiological Health. "Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart."

The device consists of one or two external pneumatic (driven by air) blood pumps, multiple tubes to connect the blood pumps to heart chambers and the great arteries, and the driving unit.

Heart failure in children is much less common than in adults. Heart transplantation offers effective relief from symptoms. However, far fewer pediatric sized donor hearts are available for transplantation than for adults, limiting the use of heart transplantation in children and prolonging the waiting period until transplant can occur. In infants, the median waiting time for a donor heart is 119 days. Overall a reported 12-17 percent of children and 23 percent of infants die while on the wait list for a heart transplant.  

In the primary U.S. study group of 48 patients, the use of the device was found to improve survival to transplant in patients when compared with the use of extracorporeal membrane oxygenation (ECMO) which is the current standard of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR Pediatric System.  

The EXCOR was designated as a Humanitarian Use Device (HUD) by the Office of Orphan Products Development at the FDA. This designation is for medical devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States annually. The device was approved under a Humanitarian Device Exemption (HDE), a type of marketing application that is similar to a premarket approval application in that the level of safety required for approval is the same. Rather than having to show a reasonable assurance of effectiveness, devices submitted under the HDE marketing route need to prove that the probable benefit from use of the device outweighs the probable risk of illness or injury from its use to obtain the FDA's approval.

The FDA approval of an HDE authorizes an applicant to market the device subject to certain use restrictions. After the passing of the Pediatric Medical Device Safety and Improvement Act of 2007, HUDs intended and labeled for use in a pediatric population are permitted to be marketed for profit.  

The FDA's Orphan Products Grant Program supported the U.S. clinical trials for the EXCOR Pediatric System with grants of $400,000 per year for three years.

For more information:

Designating Humanitarian Use Devices
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/DesignatingHumanitarianUseDevicesHUDS/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... 26, 2016 According to a new ... Market - U.S. Industry Analysis, Size, Share, Growth, Trends, and ... the U.S. was valued at US$ 5.89 Bn in 2014 ... from 2015 to 2023 to reach US$ 7.99 Bn in ... and emerging needle free drug delivery devices and the market ...
(Date:5/25/2016)... -- FDA 510(k) clearance covers Confocal ... urological and surgical applications Mauna Kea ... the multidisciplinary confocal laser endomicroscopy (CLE) platform, today ... with the 12 th 510(k) clearance from ... new FDA clearance covers Confocal Miniprobes indicated for ...
(Date:5/25/2016)... 2016  According to Kalorama Information, the world ... 2015.  Though these are challenging times in the ... success for companies that remain optimistic and seek ... growth prospects medical device companies spend a higher ... (R&D) than do companies in other industries.  Also, ...
Breaking Medicine Technology:
(Date:5/27/2016)... York, NY (PRWEB) , ... May 27, 2016 , ... ... factors of a stroke, which we as a society can control and change. , ... stroke occurs nearly every 40 seconds within the United States. Plus, with an estimated ...
(Date:5/27/2016)... ... 27, 2016 , ... Aimed at nurses and employees in ... courtesy of leaders in the nursing and health care industry. It also provides ... and associations—namely Jones & Bartlett Learning. , Jones & Bartlett Learning is adding ...
(Date:5/26/2016)... ... ... Despite last week’s media reports hinting at a June rate hike after the Federal ... an interest rate increase, according to Rajeev Dhawan of the Economic Forecasting Center at ... Committee (FOMC) dot charts are of interest to the press for their noise potential,” ...
(Date:5/26/2016)... Missouri (PRWEB) , ... May 26, 2016 , ... ... quality and clinical outcomes, hosted members and suppliers for its inaugural Member Conference ... focus on their mission of elevating the operational health of America’s healthcare providers. ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... The ... Project offering a new model of care for living and healing, celebrated its ... values: Meaningful Life in a Real Home provided by Empowered Staff. , “This is ...
Breaking Medicine News(10 mins):