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Cleveland Clinic 2004 Medical Innovation Summit In Brief

This article was originally published in The Gray Sheet

Executive Summary

Market leader or fast follower?: Guidant's ability to bypass FDA panel review and be first to the U.S. market in August with the Rx Acculink carotid stent suggests an advantage to being a "fast follower," rather than the originator of a brand-new therapy, according to vascular interventionalist Jay Yadav, MD, Cleveland Clinic Foundation. J&J/Cordis' Precise carotid stent withstood panel review and had been widely projected as the first-comer, but still awaits final FDA sign-off. "There is some consternation in the medical device community that it may be more efficient - you may save tens of millions of dollars - by waiting a couple of months and being a fast follower," Yadav claims. "Do we really want an [FDA] environment where true innovation is discouraged for business reasons?"...

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QUOTED. 25 November 2020. Ricki Chase.

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