The Wall Street Journal Health Blog profiles Berlin Heart's Excor pediatric ventricular assist device, an important offering that could help fill a void for children awaiting transplant. This need is important because currently available devices are geared toward adults and are not appropriate for children.
During a two-day session last month, an FDA expert panel reviewed both Berlin Heart's offering and Edwards Lifesciences' Sapien heart valve. There was a lot of attention paid to the meeting, during which the panel unanimously voted in favor of the Berlin Heart device.
The FDA, Berlin Heart and pediatric cardiology programs have been working to get the device approved under a humanitarian device exemption. In addition, the agency and the NIH are trying to encourage the industry to invest in the pediatric-device market, which doesn't necessarily deliver big profit, as the WSJ Health Blog points out. Currently, four other circulatory support pumps for children under 5 are being developed through the PumpKIN program, which funded by the National Heart, Lung and Blood Institute.
Berlin Heart's product has been available in Europe since 1996 and in the U.S. under a compassionate use protocol since 2000. As the company awaits the FDA's decision, implants of the Excor pediatric VAD for bridge-to-transplantion patients are continuing under the continued access protocol. The company is headquartered in Berlin and has a U.S. unit in The Woodlands, TX.
- see the WSJ Health Blog report