Jarvik Heart has announced that its new pediatric heart pump is going on a clinical trial thanks to an FDA Investigational Device Exemption. The Jarvik 15mm left ventricular assist device (LVAD), being about the size of a AA battery, is small enough even for implantation into infants. As the child grows and his cardiac needs increase, the pump can be adjusted to provide more circulatory support. It’s intended to serve kids as old as ten years old before an adult-size device would be required or an appropriate donor heart becomes available.
The trial will compare the new pump against the Berlin Heart EXCOR Pediatric System, a product that received humanitarian device exemption from the FDA back in 2011.
More about the study and the device according to Jarvik Heart:
The study is managed by the New England Research Institutes and will ultimately enroll 88 patients from about 20 institutions in the U.S. and Canada. Patients who meet study criteria will randomly receive either a Jarvik 15mm LVAD System or a Berlin Heart EXCOR Pediatric System. The study will compare the ability of the two systems to provide circulatory support as a bridge to transplant, assessed over a six-month period.
Jarvik Heart originally released its Jarvik 2000 adult model LVAD System over 15 years ago, and it remains the smallest and lightest permanent LVAD system in the world. With CE mark granted in 2005 and Japanese Shonin approval in 2013, experience with the Jarvik 2000 adult model LVAD System has enabled the miniaturization necessary to create the Jarvik 15mm LVAD System.
Via: Jarvik Heart…