The FDA has granted conditional approval to conduct an investigational device exemption (IDE) 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.
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. Therefore as the child grows, the blood flow increases. The device is designed for patients under one year up to about age 10 and may provide long-term support in children for whom no donor heart becomes available.
The study is managed by the New England Research Institutes and aims to enrol 88 patients from about 20 institutions in the US and Canada. Patients who meet study criteria will randomly receive either a Jarvik 15mm LVAD System or a Berlin Heart Excor Pediatric System. The aim of the study is to compare the ability of the two systems to provide circulatory support as a bridge to transplant, assessed over a six-month period.
A press release reports that the approval of the study is a milestone for the National Heart Lung and Blood Institute (NHLBI), which has funded the PumpKIN (Pumps for kids, infants, and neonates) programme for a decade. It adds that 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.
Peter Hinchliffe, president of Jarvik Heart, comments: “We are thankful for the NHLBI programme, 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.”
Robert Jarvik, inventor of the device and chairman of Jarvik Heart, notes: “We are excited about bringing this miniaturised pump design to paediatric heart failure patients after a decade of intense engineering effort.”
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, according to the press release, experience with the Jarvik 2000 adult model LVAD system has enabled the miniaturisation necessary to create the Jarvik 15mm LVAD System.