Article preview from IN VIVO - July 2008
Find out why three years after the start of a series of high profile recalls, cardiac rhythm management device manufacturers are struggling to recapture the public's trust and restore a reasonable fraction of the industry's once high-flying growth.
Article preview from IN VIVO - July 2008
Life After The Recalls: How the CRM Industry Hopes to Cross The Trust Gap
Early in this decade, cardiac rhythm management (CRM) devices could be counted on for 20+% annual sales growth. But today, three years after the start of a series of high profile recalls, CRM device manufacturers are struggling to recapture the public's trust and restore a reasonable fraction of the industry's once high-flying growth.
Trying to bridge this gap in trust, CRM manufacturers, the Food and Drug Administration (FDA) and the Heart Rhythm Society (HRS), have adopted new guidelines designed to increase post-market transparency to unprecedented levels. This strategy of overhauling safety protocols is intended to restore the confidence of implanting physicians and the patient community as a whole. (See "The Future of Cardiac Rhythm Management," Medtech Insight, August 2006.)
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Companies mentioned in this article:
Boston Scientific Corp.
Medtronic Inc.
St. Jude Medical Inc.
University of South Florida
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