Synergy Pocket Circulatory Assist Device Does Well in Early Trial

Synergy Pocket Circulatory Assist Device Does Well in Early Trial

CircuLite® is developing disruptive solutions to improve the treatment of chronic heart failure. The Company’s minimally-invasive circulatory support systems are intended to work in conjunction with the heart to enhance clinical outcomes and improve quality of life for patients and their families. The SYNERGY® surgical system for partial circulatory support, which has received CE Mark approval in Europe, features the world’s smallest surgically implanted blood pump designed for long-term use in patients diagnosed with chronic heart failure. Next-generation circulatory support systems in development that incorporate CircuLite’s micro-pump technology include an endovascular system, a right-heart system, a pediatric system, and an all-support system.

CircuLite’s devices are being developed for patients with chronic heart failure who are not responding to standard medical care, but are not candidates or eligible for heart transplantation. The majority of these patients will have been diagnosed with NYHA Class IIIb/early Class IV (INTERMACS 4-6) heart failure. SYNERGY is a miniature ventricular support system that is intended to offer patients clinical benefits over standard medical therapies, including reduced symptoms of heart failure and associated re-hospitalizations, as well as to improve exercise tolerance and quality of life.

SYNERGY’s Micro-pump is the size of a AA battery, provides up to 4.25 liters of blood flow per minute, and is designed 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.

CircuLite, a private, venture-backed international company, was founded 2004. CircuLite, Inc. Is headquartered in Saddle Brook, New Jersey. CircuLite GmbH, a wholly owned subsidiary of CircuLite Inc., is located in Aachen, Germany.

For a patient with end-stage heart failure, an implantable pump that helps circulate the blood can mean added months or even years of life. Now CircuLite is developing an implantable pump that weighs just one-sixth as much as its smallest predecessor. About the size of a AA battery, it could ultimately be implanted through a catheterization procedure that is far less invasive than the operations used to place today’s pumps. It could thus be used to treat patients in earlier stages of heart failure, for whom implantation surgery had previously been too risky.

Invented more than two decades ago, the earliest support pumps–or ventricular assist devices (VADs)–kept patients tethered to a large external console and a blood-thinning machine. A second generation of VADs, still widely in use, has spinning rotors that continuously draw in blood. Third-generation devices are much smaller, using magnetic or hydrostatic forces to float the rotor within the blood. That eliminates friction between the pump’s parts, which in earlier generations led to breakdowns and blood clots. But implanting these devices still requires sawing through the breastbone and placing the patient on heart-lung bypass.

CircuLite’s pump, called Synergy, uses a combination of magnetic and hydrostatic forces to suspend the rotor. But it differs from a VAD in that it sucks blood from a different chamber of the heart and returns it through a different artery. Because it is designed for patients in an earlier stage of heart failure, whose hearts can still pump a modest amount of blood on their own, the Synergy pump gets by on a smaller, less powerful motor. Unlike implantable VADs, which rest deep inside the chest cavity, the Synergy pump is small enough to be placed near the skin’s surface.

“It’s a very small, very well engineered device,” says Yoshifumi Naka, director of the Mechanical Circulatory Support Program at Columbia University Medical Center.

The device began clinical testing in Europe in June 2007 and has been implanted in nine patients so far. All nine have survived to date, and five have successfully gone on to heart transplants. CircuLite estimates that U.S. clinical trials will begin in early 2009.

The pump itself may sit just beneath the skin, but its inflow tube extends much deeper, into the left atrium of the heart. Currently, in the European studies, the surgeon goes between ribs to place the tube. This “mini-thoracotomy” is faster and safer than the full sternotomy required for most other implantable pumps, but heart-lung bypass is still required.

The Synergy Pocket Circulatory Assist device from Circulite, a company out of Saddle Brook, New Jersey and Aachen, Germany, is doing well in a European clinical trial, according to the MIT Tech Review.

According to the magazine, the device, first covered by us in Aug 2007, has been implanted in nine patients, all of them still alive and apparently doing well. Of these patients, five have successfully gone on to heart transplants, showing the device to be a potentially useful modality as a bridge to transplantation.

A quick refresher on the technology:

6578circ2 Synergy Pocket Circulatory Assist Device Does Well in Early Trial

… the Synergy Pocket Circulatory Assist device combines a superficially positioned micro-pump with inflow and outflow cannulae placed with endovascular techniques. 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…

The Synergy Pocket Circulatory Assist device works in synergy with the patient’s native heart function and pumps up to 3 liters of blood per minute (partial circulatory assist) to increase the total cardiac output (blood to body).

The hemodynamic effects of partial circulatory assist were assessed in a computer-based heart failure simulation model which predicts partial circulatory assist of 2 to 3 liter of blood flow per minute:

Decreases left ventricular end diastolic pressure by 7 to 10 mm Hg

Provides significant pressure and volume unloading of the native heart

Increases net cardiac output by ~ 1 liter of blood flow per minute

The hemodynamic effects of partial circulatory assist have also been reported in a small, single center study. Twenty patients supported on HeartMate™ VE Ventricular Assist Device (VAD), were assessed on full assist (approximately 5 liters of blood flow per minute) and partial assist (approximately 1.6 liters of blood flow per minute) which was achieved by reducing the device’s cycles per minutes setting. The authors concluded that partial circulatory assist:

Improved peak VO2 consumption

Improved myocardial function

…Synergy device micro-pump has been refined to be the smallest implantable blood pump and has several unique features that are designed to minimize the risk of thrombus formation and hemolysis.

The Synergy device 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 is the size of a AA battery with an outer body diameter of 14 mm, length of 49 mm, weight of 25 grams and pumps up to 3 liters of blood per minute.

The Synergy device micro-pump design features a unique magnetically and hydrodynamically levitated and stabilized impeller 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 impeller.

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