FDA approves mechanical cardiac assist device for children with heart failure

Having received unanimous recommendation from its Circulatory System Devices Advisory Panel to grant a humanitarian device exemption to the Berlin Heart Excor Pediatric Ventricular Assist Device (VAD), the FDA did just that.berlin-heart-excor

Here are some details from our earlier postabout the study that led to the approval:The sponsors of the VAD presented data from a recent prospective, non-randomized, multi-center, single arm study assessing the safety and probable benefit of the device.  48 children were enrolled in the trial and their outcomes were compared to those receiving ECMO (extracorporeal membrane oxygenation), which is considered the standard of care for bridging children to transplant.  Regardless of a 29% stroke rate, 90% of the children survived to transplant or were successfully weaned off the VAD.  The overall rate of serious adverse events was less in the Excor group versus the ECMO group.  Although the committee wants further investigation of the stroke rates with better-defined outcomes and causes, they do suggest this can be done in the setting of post-approval studies.

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.

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.

Source:http://medgadget.com/2011/12/berlin-heart-excor-pediatric-heart-pump-gets-fda-approval.html,http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm283956.htm

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