Our Technology
CircuLite is transforming heart failure treatment with the development of minimally invasive devices for long-term partial circulatory support (PCS). CircuLite's pipeline of PCS devices is lead by the Synergy® Pocket Micro-Pump, designed to expand the treatment options for chronic heart failure patients.
About Synergy
The Synergy Pocket Micro-Pump Device represents a new approach to mechanical circulatory support that can transform chronic heart failure management by enabling earlier, less-invasive treatment for more patients. Synergy is the first partial circulatory assist device designed for long-term use in NYHA Class IIIb/early IV patients (INTERMACS 4-6). CircuLite's patented micro-pump provides up to 3L/min of flow which increases total cardiac output, allowing the heart to rest and potentially enabling beneficial recovery of heart function. The size of a AA battery, the device is small enough to be implanted subcutaneously in a "pacemaker-like" pocket through a minimally-invasive procedure. CircuLite's development of Synergy is backed by demonstrated proof-of-concept in ongoing clinical studies and 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.
In its ultimate embodiment, the Synergy Pocket Micro-Pump device combines a superficially positioned micro-pump with inflow and outflow cannulae placed via endovascular techniques (Figure 1). Blood is drawn from the left atrium via the inflow cannula that is connected to the micro-pump which pumps the blood back to the body via the outflow graft to the subclavian artery.
| Figure 1: Synergy Endovascular Implantation |
|
|
|
How Synergy Works
The Synergy Pocket Micro-Pump device works in synergy with the patient's native heart function and pumps up to 3 liters of blood per minute, providing partial circulatory support, to increase the total cardiac output (blood to body). It is designed for long-term use and designed to be implanted either via a minimally invasive surgical or endovascular implantation procedure.
First-in-man trials of Synergy have utilized a mini-thoracotomy procedure (Figure 2).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 the pacemaker like pocket and connected to the inflow and outflow cannulae.
| Figure 2: Synergy Surgical Implantation |
|
|
|
Future clinical trials will utilize an endovascular procedure. With this approach, the catheter is placed in the left atrium transseptally from the subclavian vein and right atrium. The outflow graft is then attached to the subclavian artery and the micro-pump is placed in the pacemaker pocket.
Computer simulation and studies in preclinical models have all contributed to a growing database and knowledge base supporting proof-of-concept for Synergy and the ability to provide partial circulatory support via a superficially placed micro-pump capable of delivering up to 3L/min of blood flow. Additionally, successful First-in-Man clinical trials with the device have provided crucial human proof-of-concept for Synergy.
Patients implanted with the Synergy Micro-Pump thus far have experienced remarkable clinical improvements. Activation of the micro-pump resulted in increases in patients' cardiac output (CO), mean arterial pressure (MAP), and cardiac index (CI), as well as decreases in pulmonary capillary wedge pressure (PCWP) and improved renal function. Additionally, no clinically significant hemolysis has been observed during normal pump operation.
Computer models of acute heart failure with simulation of the effects of supplemental circulatory support have demonstrated an increase in total cardiac output of approximately 1 L/min and a reduction in left ventricular end diastolic pressure of about 8mmHg. Studies in preclinical models have demonstrated the feasibility of micro-pump implantation in a pacemaker-like pocket and placement of the inflow and outflow cannulae via mini-thoracotomy. Preclinical testing of the Synergy system, including over 4,500 total days of partial circulatory support (with no anticoagulation or platelet inhibition therapy), yielded no clinically significant hemolysis. These studies also confirmed the viability of the implantation techniques developed in the cadaver model and the physiological effects of partial support that were demonstrated in computer models.
Synergy's Micro-pump
The Synergy Pocket Micro-Pump device features a micro-implantable blood pump which can be superficially placed with minimally-invasive surgical or endovascular techniques. Current clinical trials utilize a surgical procedure, while future trials will incorporate endovascular implantation techniques. Therefore, in the future, both interventional cardiologists and surgeons will potentially be able to implant the device.
The micro-pump’s development began in 1996 at the Helmholtz Institute for Biomedical Engineering in Aachen, Germany, one of the world’s leading centers for blood pump technology development. Over these years of development, the micro-pump has been refined to be the smallest implantable blood pump - the size of a AA battery and weighing only 25 grams - and has several unique features that are designed to minimize the risk of thrombus formation and hemolysis.
Synergy's micro-pump combines axial, centrifugal and orthogonal flow paths with a single-stage impeller that is powered by an integrated brushless micro-electric motor (Figure 3). The micro-pump is the size of a AA battery with an outer body diameter of 14 mm, length of 49 mm, weight of 25 grams (Figure 4) and pumps up to 3 liters of blood per minute.
| Figure 3: Micro-Pump blood flow path |
Figure 4: Synergy Micro-Pump |
|
|
|
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 the potential of thrombosis formation. The micro-pump also features a proprietary self-washing flow path that minimizes the risk of thrombus formation in or around the rotor.
Synergy Power System
A lightweight, rechargeable dual battery pack system and controller have been designed to control and power the Synergy Pocket Micro-Pump device (Figure 5). The power system weighs approximately 3.3 pounds and the dual battery pack will power the system for approximately 16 -18 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. CircuLite's next-generation batteries will further reduce the weight of the system.
| Figure 5: Power System |
|
|
|
|
| Because the Synergy Pocket Micro-Pump device works in conjunction with the patient’s native cardiac flow and function, there is a built in “fail-safe” mechanism in the event of an accidental power disconnect. The patient would be supported by their native cardiac flow (“fail-safe” mechanism) until they are able to restore power, so an accidental power disconnect would not represent an immediate life-threatening situation. |
