News | July 29, 2009

CircuLite Awarded NIH Grant to Develop Pediatric VAD

The Synergy Micro-Pump

July 29, 2009 – CircuLite Inc. said today it was awarded a Fast-Track Phase I-II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to fund the development of a pediatric circulatory assist device based upon CircuLite’s Synergy Pocket Micro-pump.

CircuLite, who will collaborate with the University of Maryland School of Medicine on the grant, has received funding from the National Heart, Lung and Blood Institute at NIH to support the first phase of the grant. The total potential award for phase I and phase II could reach up to $3.7 million. Synergy is a micro-blood pump, the size of a AA battery, that can be implanted superficially in a pacemaker-like pocket. Synergy is the first and smallest device designed for partial circulatory support (up to 3 L/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.

The Synergy device was designed to provide partial circulatory support for the failing adult heart, but its small design makes it a logical candidate for a pediatric application after modification. The aim of phase I of this grant is to modify the current CircuLite device such that it will be useable in a child and to determine the feasibility of short-term in vivo use. In phase II, the child system will be finalized and examined in a long-term in vivo study and an infant device will be developed and tested.

The company said the NIH grant is a strong endorsement for its unique approach to heart failure treatment, as well as its potential utility to pediatric patients due to its small size and minimally invasive implantation. The current European 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, the company said.

“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., coinvestigator 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.”

For more information: www.CircuLite.net

Related Content

FDA Class I Recall Issued for Medtronic HeartWare HVAD Pump
News | Ventricular Assist Devices (VAD) | May 29, 2020
May 29, 2020 — Medtronic is recalling its HeartWare HVAD...
Abiomed Receives FDA PMA Approval for Impella 5.5 With SmartAssist
Technology | Ventricular Assist Devices (VAD) | September 27, 2019
Abiomed’s newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre...
CorWave Presents First Successful In Vivo 60-day Study of Neptune LVAD
News | Ventricular Assist Devices (VAD) | September 12, 2019
CorWave announced successful completion of its first 60-day preclinical study to evaluate its Neptune left ventricular...
Experts Caution Against Catch-all Assumptions About LVADs and Mitral Regurgitation

Paul Tang, M.D., Ph.D., a cardiac surgeon at Michigan Medicine’s Frankel Cardiovascular Center in the OR. Image courtesy of Michigan Medicine.

News | Ventricular Assist Devices (VAD) | August 20, 2019
Left ventricular assist devices (LVADs) have been shown to help leaky mitral valves that create significant...
FDA Confirms Impella RP is Safe and Effective
News | Ventricular Assist Devices (VAD) | June 12, 2019
 In a letter sent to healthcare providers, the U.S. Food and Drug Administration (FDA) validates that Abiomed’s Impella...
Impella SmartAssist Platform Launches at SCAI
News | Ventricular Assist Devices (VAD) | May 22, 2019
Abiomed announced that the Impella CP with SmartAssist will be commercially available beginning at the 2019 Society for...
FDA Approves Impella 5.0 and Impella LD Extended Duration of Use
Technology | Ventricular Assist Devices (VAD) | May 14, 2019
The U.S. Food and Drug Administration (FDA) has approved the expansion of Abiomed’s Impella 5.0 and Impella LD...
FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial
News | Ventricular Assist Devices (VAD) | May 02, 2019
Abiomed announced that, on April 26, the U.S. Food and Drug Administration (FDA) approved initiation of the ST-...
Cardiogenic Shock Survival Rates Improve in Three Years Since Impella FDA Approval
News | Ventricular Assist Devices (VAD) | April 05, 2019
Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket...