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The AB-180 circulatory support system: summary of development and plans for phase I clinical trial
E B Savage1, R E Clark, W P Griffin
1Allegheny General Hospital, Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, USA.
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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