Image: The Synergy Circulatory Support System (Photo courtesy of CircuLite).
A surgically implanted micropump aids ambulatory chronic heart failure (CHCF) patients who not respond to optimal medical treatment.
The Synergy Circulatory Support System is designed to reverse HF symptoms in ambulatory patients, promoting significant hemodynamic improvements, including decreased pulmonary artery and pulmonary capillary wedge pressures and increased cardiac output. The device provides up to 4.25 liters of blood per minute, reducing the heart's workload while improving blood flow to the final organs. The system is surgically implanted using a mini-thoracotomy procedure and the micro-pump is placed in a pacemaker-like pocket. The procedure is intended to reduce the surgical risks associated with cardiopulmonary bypass support platforms needed to place current ventricular assist devices (VADs).
The micropump combines axial, centrifugal, and orthogonal flow paths with a single-stage impeller that is powered by an integrated brushless microelectric motor; the entire system is the size of a standard AA battery. The design allows the motor to be sealed, thus eliminating blood contact in the motor, as well as a proprietary self-washing flow path and an alternating speed algorithm, both designed to minimize the risk of thrombus formation in or around the rotor. The Synergy Circulatory Support System is a product of CircuLite (Aachen, Germany) and has received the European Community CE marking of approval.
“The latest version of the Synergy System was shown to improve hemodynamics and functional status with comparably low adverse event rates in chronic ambulatory heart failure patients,” said Professor Bart Meyns, MD, PhD, chief of cardiac surgery at the University Hospitals Leuven (Belgium), who conducted the study in the final 26 patients of the clinical Synergy CE-Mark Trial. “The System has the potential for broad application in earlier-stage patients, who are not sick enough to justify the risks associated with more surgically-invasive assist devices.”
“The final modifications we made to the Synergy System have made a significant clinical difference, which was demonstrated in our clinical trial,” said Paul Southworth, CEO of CircuLite. “We showed positive outcomes and we have lowered adverse events in comparison to larger devices.”