Data and Publications

Synergy Clinical Data Overview

In 2007, CircuLite initiated a multi-center clinical trial in Europe to support efforts to obtain CE Marking for the Synergy miniature ventricular support system. This trial is ongoing and evaluating the safety and patient quality of life improvements associated with device support of greater than six months.

 

Data from the on-going trial has shown that supplemental circulatory support with Synergy can provide statistically significant and sustained improvements and a reduction of symptoms of heart failure. Patients supported with Synergy have experienced long-term hemodynamic improvements, including increases in cardiac index, as well as decreases in pulmonary capillary wedge pressure and maintained or improved renal function.¹

 

 

Patients supported with Synergy have also experienced long-term improvements in their functional status and quality of life, including clinically meaningful improvements in hemodynamics that correlate with preserved (or improved) renal function, improved exercise tolerance and improved quality of life. Patients have also been able to easily manage the external components of the system.¹

 

 

Prior to the initiation of the human clinical trial, computer models of acute heart failure with simulation of the effects of supplemental circulatory support demonstrated an increase in total cardiac output and a reduction in left ventricular end diastolic pressure. Additionally, studies in preclinical models demonstrated the feasibility of micro-pump implantation in a pacemaker-like pocket and placement of the inflow cannula and outflow cannula graft via mini-thoracotomy. Preclinical testing in animals of the Synergy system, with no anticoagulation or platelet inhibition therapy, yielded no clinically significant hemolysis.²

 

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¹Meyns B, Simon A, Klotz S, Wittwer T., Schlensak C. Rega F, Burkhoff D. Clinical benefits of partial circulatory support in New York Heart Association Class IIIb and Early Class IV patients. European Journal of Cardio-thoracic Surgery, 39 (2011) 693-698.

 

²Data on file, CircuLite, Inc.

Publications

• Meyns B, Simon A, Klotz S, Wittwer T., Schlensak C. Rega F, Burkhoff D. Clinical benefits of partial circulatory support in New York Heart Association Class IIIb and Early Class IV patients. European Journal of Cardio-thoracic Surgery, 39 (2011) 693-698.
• Klotz S, Meyns B, Simon A, Wittwer T, Rahmanian P, Schlensak C, Tjan T, Scheld H, Burkhoff D. Partial Mechanical Long-Term Support with the CircuLite^® Synergy^® Pump as Bridge-to-Transplant in Congestive Heart Failure. Thoracic Cardiovascular Surgery 2010; 58, S173-S178.
• Meyns B, Rega P, Ector J, Droogne W, Vanhaecke J, Van Hemelrijck J,Griffith B, Dowling R, Zucker M, MD, Burkhoff D. Partial left ventricular support implanted through minimal access surgery as a bridge to cardiac transplant. The Journal of Thoracic and Cardiovascular Surgery 2009; Vol. 137, No. 1, 243-245.
• Meyns B, Klotz S, Simon A, Droogne W, Rega F, Griffith B, Dowling R, Zucker M, Burkhoff D. Hemodynamic response to long-term partial ventricular support with the Synergy Pocket Micro-Pump. JACC 2009; Vol. 54, No. 1, 79-86.
• Meyns B, Ector J, Rega F, Droogne W, Vanhaecke J, Vanhemelrijck J, Griffith B, Dowling R, Zucker M, Burkhoff D. First human use of partial left ventricular heart support with the CircuLite synergy micro-pump as a bridge to cardiac transplantation. European Heart Journal 2008.
• Heart and Stroke Statistical update, American Heart Association, 2012.
• Burkhoff D, Klotz S, Mancini D. LVAD-Induced Reverse Remodeling: Basic and Clinical Implications for Myocardial Recovery. J Card Fail, 2006; 12(3) 227-239.
• Morley D, Litwak K, Ferber P, Spence P, Dowling R, Meyns B, Griffith B, Burkhoff D. Hemodynamic effects of partial left ventricular support in chronic heart failure: results of simulation validated with in vivo. JTCVS, 2006; 132:459-463.
• Mancini D, Burkhoff D. Mechanical device-based methods of managing and treating heart failure. Circulation 2005; 112(3):438-448.
• Meyns B, Stolinski J, Leunens V, Verbeken E, Flameng W. Left ventricular support by catheter mounted axial flow pump reduces infarct size. Journal of the American College of Cardiology 2003; 41(7):1087-1095.
• Hunt, SA, Baker DW, Chin MH, et al. ACC/AHA guideline for the evaluation and management of chronic heart failure in the adult: executive summary. J Heart Lung Transplant, 2002; 21: p. 189-203.
• Maybaum S, Epstein S, Beniaminovitz A, Di Tullo M, Oz M, Bergmann SR, Mancini D. Partial loading of the left ventricle during mechanical assist device support is associated with improved myocardial function, blood flow and metabolism and increased exercise capacity. J Heart Lung Transplant 2002; 21:446-454.
• Meyns B, Siess T, Nishimura Y, Racz R, Reul H, Rau G, Leunens V and Flameng W. Miniaturized implantable rotary blood pump in the atrial-aortic position supports and unloads the failing ventricle. Cardiovascular Surgery 1998; 6(3): 288-295

 

"CircuLite is not affiliated with any of the proprietors of these references, and none of these proprietors endorses or sponsors CircuLite."