Saturday, January 7, 2012

FDA's Recent Actions

Recently, FDA approved a medical device that can support the weakened hearts of children with heart failure so they will live until a donor for a heart transplant can be found. The mechanical pulsatile cardiac assist device called the EXCOR Pediatric System made by Berlin Heart comes in graduated sizes to fit children from newborns to teens.

Heart failure in children is much less common than in adults. Heart transplantation offers effective relief from symptoms, however, there are far fewer pediatric-sized donor hearts available for transplantation than for adults. For infants, the average waiting time for a donor heart is 119 days. Overall, a reported 12 to 17 percent of children and 23 percent of infants die while on the waiting list for a heart transplant.

The EXCOR was designated as a Humanitarian Use Device by the Office of Orphan Products Development at FDA. This designation is made 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 U.S. annually. 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.

In another FDA action, FDA now allows the marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas using near-infrared spectroscopy. The device called the “Infrascanner Model 1000” manufactured by InfraScan Inc. of Philadelphia, can help healthcare providers identify patients with critical head injuries who need an immediate brain imaging study. Intracranial hematomas occur when blood from a ruptured blood vessel collects within the brain or between the skull and the brain.

The scanner directs near-infrared light which is a wavelength of light that can penetrate tissue and bone into the skull. Blood from intracranial hematomas absorb light differently than from other areas of the brain. The scanner is able to detect differences in light absorption and then transmit this information wirelessly to a display on a hand-held computer.

By comparing the optical density from a series of scans for specific areas on both sides of the skull, a trained healthcare provider can use the information provided by the device, in conjunction with other clinical information to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures such as a CT scan.

“As a result, this portable device can offer emergency room physicians a non-invasive mechanism to aid in assessing whether an immediate CT scan is needed”, according to Christy Foreman, Director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.