Jarvik moves closer to FDA approval for tiny heart implant for kids

Jarvik Heart got an FDA OK for a study of its tiny heart implant for babies and children. The news moves the company one step closer to getting the device approved in the U.S.

Regulators granted conditional approval for a study that pits Jarvik’s new miniature left ventricular assist device (LVAD), the Jarvik 2000, against a competing device, the Berlin Heart EXCOR. The trial will include 88 patients from 20 institutions in the U.S. and Canada and will look at how well the devices work over 6 months in children who need heart implants, Jarvik said in a statement.  

The green light marks a milestone for Jarvik, which has been working hard over the past 10 years to get Jarvik 2000 approved in the U.S. The device is already approved in Europe and Japan.

Jarvik markets Jarvik 2000 as the “smallest and lightest permanent LVAD system in the world,” the company said in a statement. The 15 mm pump that will be included in the study is about the size of one AA battery and is meant for children who are waiting for an implant.

The pump increases blood flow to the heart as a child grows. It can be used from infancy to 10 years of age, Jarvik said, potentially offering long-term support to kids without heart donors.

Jarvik has already run animal studies of the device through a program run by the National Heart Lung and Blood Institute (NHLBI). The results were good enough to prompt investigational trials of the device in children, the company said.

“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,” Jarvik President Peter Hinchliffe said in a statement.