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Ann Thorac Surg 1999;68:768-774
© 1999 The Society of Thoracic Surgeons

Innovative Circulatory Support Systems

The AB-180 circulatory support system: summary of development and plans for phase I clinical trial

Edward B. Savage, MDa, Richard E. Clark, MDa, Wayne P. Griffin, MSa, Scott A. Davisa, Suzanne Hughson, MSa, Christopher J. Conway, MSa, George J. Magovern, Sr, MDa

a Allegheny General Hospital, Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, USA

Address reprint requests to Dr Savage, Department of Cardiothoracic-Vascular Surgery, Rush University, Suite 1156, 1725 West Harrison St, Chicago, IL 60612

Presented at the Fourth International Conference on Circulatory Support Devices for Severe Cardiac Failure, Houston, TX, Oct 3–5, 1997.

Abstract

Background. The AB-180 circulatory support system is a small, durable, efficient centrifugal pump with low thrombogenic potential. The device was designed to provide a fully implantable, left ventricular assist system for short-term support to address the issues of systemic anticoagulation, thrombus formation, infection, and cost.

Methods. Extensive bench and animal studies were performed to validate the mechanical integrity of the device and its functionality as an implant.

Results. These studies demonstrated anticoagulation requirements, established operating guidelines, incorporated safety systems, and demonstrated safety and efficacy.

Conclusions. The AB-180 fulfills the stated goals on initial evaluation. A phase I human trial is underway.




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