Synergy is a micro-blood pump, the size of a AA battery,which can be implanted superficially in a “pacemaker-like” pocket. Synergy is the device designed for partial circulatory support (up to 3L/min) and long-term use in adult patients with Class IIIb and early Class IV heart failure. Synergy is currently in a CE Mark clinical trial at multiple centers in Europe.
“This NIH grant is a strong endorsement for Synergy’s unique approach to heart failure treatment, as well as its potential utility to pediatric patients due to its small size and minimally invasive implantation procedure,” said Paul Southworth, President and CEO of CircuLite. “While other devices are in development for children and infants, CircuLite believes that Synergy has unique advantages over these other technologies, particularly given its prior successful experience in human clinical trials and its later stage of development as we approach European CE Mark approval later this year. The current study in adults has shown that partial circulatory support provided by Synergy unloads the heart and improves hemodynamics, which can translate into important improvements in functional status and quality of life.”
“Existing devices do not meet the need for circulatory assistance in pediatric patients, even as hundreds of infants and children with congenital or acquired cardiovascular disease die each year while waiting for a donor heart,” said Bartley P. Griffith, M.D., co-investigator on the grant. Dr. Griffith is chief of the Division of Cardiac Surgery and director of Heart and Lung Transplantation in the Department of Surgery at the University of Maryland Medical Center in Baltimore and a professor of surgery at the University of Maryland School of Medicine. “To-date, ventricular assist devices designed for adults have not successfully been redesigned for infants and children, due to difficulties in the miniaturization process of these devices. The goal of this NIH grant is to develop long-term implantable miniature partial circulatory support devices for infants and children, built upon the technology of the already micro-sized Synergy device.”