Jarvik Heart said today that the FDA approved an investigational device exemption trial of its miniature left ventricular assist device in patients of less than 1 year of age to 10 years.
The 88-patient study is designed to compare the Jarvik 15mm LVAD with Berlin Heart‘s Excor device as a bridge to transplant over 6 months.
New York City-based Jarvik said its miniature LVAD is designed to increase blood flow as the child grows. The device is roughly the size of a AA battery, Jarvik Heart said.
“We are excited about bringing this miniaturized pump design to pediatric heart failure patients after a decade of intense engineering effort,” chairman Dr. Robert Jarvik said in prepared remarks.
“We are thankful for the NHLBI program, without which this effort to provide lifesaving support for children would not have been possible. We look forward to the day when infants and children will be able to receive a fully-implantable LVAD that will enable a greatly-improved quality of life over currently-available options,” added president Peter Hinchliffe.
