Healthcare Equipment and Supplies
Company Overview of CircuLite, Inc.
CircuLite, Inc., a cardiovascular device company, engages in the design and development of minimally-invasive devices for long term partial circulatory support. It provides Synergy Pocket Micro-pump, an implantable blood pump. The company was founded in 2004 and is headquartered in Saddle Brook, New Jersey. As of December 1, 2013, CircuLite, Inc. operates as a subsidiary of Heartware International Inc.
250 Pehle Avenue
Saddle Brook, NJ 07663
Founded in 2004
Key Executives for CircuLite, Inc.
Managing Director of CircuLite GmbH
Chairman of Scientific Advisory Board and Chief Medical Officer
Compensation as of Fiscal Year 2013.
CircuLite, Inc. Key Developments
Heartware International Inc., CircuLite, Inc. - M&A Call
Dec 2 13
To discuss the Acquisition Of CircuLite(R), Inc. by Heartware International Inc
CircuLite, Inc. Receives Approval to Begin CE Mark Trial for SYNERGY(R) IC Circulatory Support System
May 15 13
CircuLite, Inc. announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of the SYNERGY(R) IC Circulatory Support System, the first mechanical support system that does not require major surgery. The SYNERGY IC System is based on the surgical SYNERGY(R) Circulatory Support System -- the world's smallest commercially available circulatory support pump - which is designed to treat ambulatory chronic heart failure patients (INTERMACS >=4). While the SYNERGY IC Circulatory Support System uses the same superficially placed micro-pump platform as the surgical system, it is the first implantable circulatory support system whose Inflow Cannula is designed to be implanted by a cardiologist using standard interventional techniques. The procedure is designed to further reduce the invasiveness of implantation, and thereby reduce the rate and severity of adverse events. The multi-center CE Mark trial will enroll up to 20 patients, starting in Belgium and expanding to two additional European clinical sites. Clinical status, end organ function, exercise tolerance, functional capacity and quality of life will be assessed post-implantation. Patient screening has commenced at the University Hospitals Leuven, Belgium.
CircuLite Inc. Announces 90-Day Results for its CE Mark Trial of the SYNERGY(R) Circulatory Support System
Apr 29 13
CircuLite Inc. announced 90-day results for the final 26 patients in its CE Mark Trial of the SYNERGY(R) Circulatory Support System, which were discussed in an oral presentation at the 33rd meeting of the International Society for Heart and Lung Transplantation. The patients were implanted with the final, commercial version of the SYNERGY System, which demonstrated clinically meaningful and sustained hemodynamic improvements, with a relatively low rate of adverse events when compared with larger support devices. The last 26 consecutive patients in the CE Mark Trial -- out of the total 63-patient trial set -- were treated with the optimized SYNERGY System. Ninety-day follow-up from these non-inotrope dependent INTERMACS >=4 patients showed significant hemodynamic improvements, including decreased pulmonary artery and pulmonary capillary wedge pressures, and increased cardiac output. Peak VO2, the six-minute walk test and the Minnesota Living with Heart Failure Questionnaire also demonstrated significantly improved functional status and quality of life. Major adverse events, such as bleeding, infection and stroke, trended lower than published studies of larger support devices. The SYNERGY System was also featured in one additional oral presentation and two poster presentations at ISHLT. The oral presentation and one poster featured animal studies of an investigational right heart application of the SYNERGY System to treat pulmonary arterial hypertension, which demonstrated that right ventricular support may improve both systemic and pulmonary hemodynamics. The other poster presentation reviewed an animal study of an investigational endovascular implantation of the SYNERGY System, which demonstrated the feasibility of deploying a novel Inflow Cannula transseptally, via venous access to the left atrium for implantation with no complications.
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December 1, 2013