CircuLite® Synergy® Micro-Pump LVAD

synergy surgical systemCAUTION: Investigational Device. Limited by Federal Law to Investigational Use Only.

Synergy is a miniature ventricular support system that offers the potential of a new minimally invasive treatment option for patients with chronic heart failure who are not responding to standard medical care. The system’s less invasive implant procedure is intended to reduce the surgical risks associated with implant procedures that require the use of a heart lung bypass machine. In addition, Synergy is intended to reduce symptoms of heart failure and associated re-hospitalizations, as well as to improve exercise tolerance and quality of life.

The Synergy system is comprised of CircuLite’s proprietary Micro-pump, inflow cannula and outflow graft, a percutaneous lead that is connected to a wearable external controller and a lightweight, rechargeable dual battery pack system. Synergy's Micro-pump is the size of a AA battery, provides up to 4.25 liters of blood flow per minute. Its role is to reduce the heart's workload and improve blood flow to the body. Synergy augments the heart's blood output while continuing to allow the heart to respond to patient needs. The system is implanted through a small incision in the upper chest and placed in a pocket created by the surgeon below the clavicle (pacemaker-like pocket).

The Power System

circulite batteryA wearable, lightweight, rechargeable dual battery pack system and controller are used to control and power the Synergy system. The power system weighs approximately 1.0 kg / 2.2 pounds and the dual battery pack will power the system for approximately 6- 8 hours. The controller provides the patient with information on the battery status and alerts the patient to any change that needs attention. The Micro-pump is connected to the power system via a percutaneous lead that exits the body in the abdominal area. The power system is designed to allow un-tethered (not connected to an electrical outlet) patient mobility and a return to activities of daily living. An important feature of the Synergy system is its ability to work in conjunction with the patient’s native remaining heart function. In the event of accidental power disconnection, most patients should be supported by their remaining cardiac output until power can be restored to the system.