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Worldheart files for extend cardiac pump use:

This article was originally published in Clinica

Executive Summary

WorldHeart has submitted a premarket approval supplement to the US FDA to expand the use of its Novacor cardiac assist device. The Oakland, California firm is seeking to use the left ventricular assist system as a long-term, or "destination", therapy in heart failure patients who are not candidates for heart transplantation. The device is already approved by the FDA as a bridge to transplantation. The FDA has yet to approve an assist device as a long-term treatment for heart-failure patients. WorldHeart is one of several cardiac assist device manufacturers seeking approval for this indication (see Clinica No 999, p 1).





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