Some children globally are suffering from cardiac-related problems, which can either be congenital or acquired, that can lead to heart failure. Cases of cardiac failure occurs less in children, than in adults. Heart failure, in some cases, necessitates a transplant, but what if a donor has not been found yet? Very recently, a medical device has been approved by the U.S. Food and Drug Administration, which can support the weak heart of affected children with heart failure. This will aid in keeping them alive until a donor has been found for heart transplant. Berlin Heart is the German company responsible in creating this so-called EXCOR Pediatric System (mechanical pulsatile cardiac assist device). This is available in graduated sizes to suit children from newborns to teens.

According to Susan Cummins, MD, MPH (chief pediatric medical officer in the FDA’s Center for Devices and Radiological Health), this device is the first FDA- approved pusatile mechanical circulatory support device designed especially for children, so this is considered as a step forward. She added that adult heart assist devices developed before were too big to fit seriously ill children, in order to keep them alive, while awaiting for a heart donor. Moreover, the device is composed of one or 2 external pneumatic (driven by air) blood pumps, multiple tubes connecting the blood pumps to heart chambers and the great arteries, and the driving unit.

Heart transplant is considered to produce symptom relief effectively. Nonetheless, compared with adults, there are less pediatric sized donor hearts available for transplantation. This can result to a prolonged waiting time for a transplant to happen. The average waiting period for a donor heart among infants is 119 days. Generally, while waiting for a heart transplant, about 12-17% of children and 23% of infants were said to die.

In the main US research group of 48 patients, the use of this EXCOR Pediatric System was revealed to result to better survival rates until transplant, in contrast with ECMO (Extracorporeal Membrane Oxygenation), the current standard of care used though not yet approved by FDA. However, stroke that may cause serious brain damage is a risk of this new technology.

EXCOR was tagged as a HUD (Humanitarian Use Device) by the FDA-Office of Orphan Products Development. Designated as such, this medical device is projected to assist patients in the treatment or diagnosis of a condition affecting less than 4,000 people in the US every year. Furthermore, FDA approved this under HDE (Humanitarian Device Exemption); this is marketing application akin to a premarket approval application where the mandatory safety level is similar. To achieve the FDA’s approval, these devices under this marketing course should prove that the benefits gained from it offset the possible danger of illness or injury.

Additionally, an HDE’s FDA approval permits the applicant to market the technology but with specific restrictions in its usage. HUDs labeled for pediatric usage are allowed to be marketed for profit, after the Pediatric Medical Device Safety and Improvement Act of 2007 had been passed. With grants of $400,000 annually for 3 years, the FDA’s Orphan Products Grant Program gave support to the US clinical trials of EXCOR Pediatric System.

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