The U.S. Food and Drug Administration (FDA) has granted conditional approval to conduct an Investigational Device Exemption study of Jarvik Heart’s new miniature Left Ventricular Assist Device (LVAD) System. The study will compare the implanted, portable electrically-powered Jarvik 15mm LVAD System with the Berlin Heart EXCOR Pediatric System.
Jarvik Heart, Inc. is the manufacturer of the Jarvik 2000 adult model LVAD System, which has been used by more than 1,000 patients worldwide for up to ten years.
The 15mm-diameter infant-size pump is about the size of one AA battery and provides more blood flow as the pump speed is increased by adjustment of the control system, so as the child grows, so does the blood flow. The device is designed for patients under one year up to about age ten and may provide long-term support in children for whom no donor heart becomes available.
The approval is a milestone for the National Heart Lung and Blood Institute (NHLBI), which has funded the PumpKIN program (Pumps for Kids, Infants, and Neonates) for a decade. Jarvik Heart overcame the many high technical hurdles and demonstrated the excellent results in animal studies necessary to begin investigational use in children who otherwise have little hope of survival.
Robert Jarvik, MD, inventor of the device and Chairman of Jarvik Heart, notes, “We are excited about bringing this miniaturized pump design to pediatric heart failure patients after a decade of intense engineering effort.”
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.
Peter Hinchliffe, President of Jarvik Heart, adds, “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 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.