Jarvik Heart has secured conditional approval from the US Food and Drug Administration (FDA) to conduct clinical trial of its new miniature pediatric heart assist device dubbed as the Left Ventricular Assist Device (LVAD) System.
The Manhattan-based ventricular assist device company will compare the LVAD System with the Berlin Heart EXCOR Pediatric System during the study. Jarvik’s LVAD System, which is of 15 mm size and electrically-powered, can be implanted while also being portable.
Managed by the New England Research Institutes, the clinical trial named as the “Investigational Device Exemption” study will eventually enroll 88 patients from about 20 US and Canada institutions.
Enrolled patients having met the study criteria will be randomly given either a Berlin Heart EXCOR Pediatric System or a Jarvik 15mm LVAD System.
The two systems will be compared and assessed over a period of six months with respect to their ability to provide circulatory support as a bridge to transplant.
Jarvik Heart in 2010 was awarded a contract from the National Heart, Lung, and Blood Institute (NHLBI) to start preclinical testing of devices to assist children born with congenital heart defects or those who develop heart failure.
Jarvik Heart president Peter Hinchliffe 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’s LVAD System is a miniaturized pump designed for pediatric heart failure patients. According to the device manufacturer, the LVAD System pumps more blood flow with the increase in pump speed by adjusting the control system corresponding to the child’s growth.
It is claimed to provide long-term support for patients from under one year up to about age ten, and is especially useful for children for whom donor hearts are not available.