About Synergy

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 cardiopulmonary bypass support. 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, and is intended to reduce the heart's workload while improving blood flow to vital organs. Synergy supplements the heart's native pumping capacity and preserves its ability to respond to the patient's cardiac output demands. The system is surgically implanted using a mini-thoracotomy and the Micro-pump is placed in a pacemaker-like pocket.

 

 

 

 

Patient Population

The Synergy system is designed for long-term use in patients diagnosed with NYHA Class IIIb/early Class IV (INTERMACS 4-6) heart failure, who typically:

 

• Suffer from compromised quality of life,
• Are symptomatic despite optimal medical therapy,
• Are ambulatory, though often house-bound,
• Have frequent hospitalizations for management of heart failure symptoms and
• Retain some intrinsic cardiac output and reasonably normal end-organ function.

 

The Micro-pump

The Micro-pump combines axial, centrifugal and orthogonal flow paths with a single-stage impeller that is powered by an integrated brushless micro-electric motor. The Micro-pump design features a unique magnetically and hydrodynamically levitated and stabilized rotor design. The design allows the motor to be sealed, thus eliminating blood contact in the motor and minimizing the potential of thrombosis formation. The Micro-pump also features a proprietary self-washing flow path and a proprietary alternating speed algorithm that is designed to minimize the risk of thrombus formation in or around the rotor.  The Micro-pump is superficially placed in a pacemaker-like pocket with minimally-invasive techniques. CircuLite's development of the Micro-pump is backed by eight years of engineering at the Helmholtz Institute in Aachen, Germany, one of the world's leading centers for blood pump technology development, in collaboration with Katholieke Universiteit in Leuven, Belgium.

 

The Power System

A 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.

 

The Procedure

Synergy’s innovative design and implantation procedures allow cardiothoracic surgeons to implant the device in approximately 90 minutes, potentially reducing risk and enabling faster patient recovery.

 

Clinical trials of Synergy have utilized a right mini-thoracotomy procedure which does not require cardiopulmonary bypass. With this approach, the inflow cannula is placed into the left atrium and the outflow graft is attached to the subclavian artery. The Micro-pump is then placed in a pacemaker-like pocket and connected to the inflow cannula and outflow graft.