SYNERGY Mini Heart Assist Pump from CircuLite Now Cleared in Europe

SYNERGY Mini Heart Assist Pump from CircuLite Now Cleared in Europe

SADDLE BROOK, N.J. and AACHEN, Germany (September 5, 2012) — CircuLite®, Inc. today announced that it has received CE Marking approval for the SYNERGY® Circulatory Support System, a micro-pump designed to halt the progression of heart failure. By working with the heart’s native pumping capacity, SYNERGY is specifically targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management.

SYNERGY is approximately the size of a AA battery and is implanted superficially in a pacemaker-like pocket under the right collarbone. SYNERGY is approximately 90 percent lighter than existing ventricular assist devices (VADs), and unlike VADs, implantation of SYNERGY is faster and does not require an open-chest procedure or cardiopulmonary bypass.

CE Marking approval was based on positive clinical results from 44 patients in an ongoing, multi-center European trial, recently presented at the International Society for Heart and Lung Transplantation (ISHLT) meeting. A total of 59 patients have been implanted with the SYNERGY System in the CE Mark trial at 9 European centers.

“There is currently a gap in the treatment of heart failure, with no satisfactory options available for patients who are not responding to standard medical therapy. SYNERGY, with its small size, minimally invasive procedure and relatively fast procedure time, is ideally suited for these patients,” said Bart Meyns, M.D., Ph.D., Professor and Chief of Cardiac Surgery at Gasthuisberg University Hospital and Principal Investigator of CircuLite’s clinical study. “In my experience with this technology, the results have been remarkable. Patients typically recover from the procedure quickly and are soon after able to perform many activities that they could not do before. This technology allows me to provide a new treatment strategy for a large number of patients who previously had no definitive options.”

“The European approval of SYNERGY is a significant milestone both for CircuLite and, more broadly, for the treatment of heart failure,” said Paul Southworth, President and Chief Executive Officer of CircuLite. “SYNERGY changes the paradigm of heart failure treatment for those who are not responding to standard medical management by working as a complement to the heart’s function. The benefits are multifaceted—patients feel better, recover rapidly and are discharged quickly—which provides the potential for a cost reduction impact for hospitals. With CE Marking in place, we will begin a controlled launch of this groundbreaking advancement in select European markets.”

About the SYNERGY® Circulatory Support System

The SYNERGY Circulatory Support System is a micro-blood pump that provides up to 4.25 liters of blood per minute and reduces the heart’s workload, while improving blood flow to vital organs. The system is surgically implanted using a mini-thoracotomy and is placed in a pacemaker-like pocket. In a clinical study, SYNERGY improved hemodynamics, exercise capacity and overall quality of life. SYNERGY is designed and manufactured in Aachen, Germany.

About CircuLite®

CircuLite is developing disruptive solutions to improve the treatment of heart failure. The Company’s technologies work in conjunction with the heart to enhance clinical outcomes and improve quality of life. SYNERGY®, which recently received CE Marking approval, features the smallest surgically implanted blood pump for long-term use in patients with heart failure not responding to standard medical treatment. For more information, visit our website at www.circulite.net.

CAUTION: Investigational Device. Limited by United States Law to Investigational Use Only.

CircuLite® and SYNERGY® are registered trademarks of CircuLite, Inc. in the United States.

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. SYNERGY received CE Mark approval in Europe in September 2012.

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 thrombus 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.

Synergy device shot

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. An important feature of the SYNERGY system is its ability to work in conjunction with the patient’s remaining native heart function. In the event of accidental power disconnection, patients may be supported by their remaining cardiac output until power can be restored to the system.

Image of the controller and battery pack

The Procedure

SYNERGY’s innovative design and implantation procedures allow cardiothoracic surgeons to implant the device in as short as 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.

Source : http://www.circulite.net/news-events/press-releases-2012-09-05.php

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