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This article was originally published in The Gray Sheet

Executive Summary

CoreValve gets reg affairs in order: Kalathi Thyagarajan, PhD, joins as VP-regulatory affairs & quality assurance. Thyagarajan, who has consulted for CoreValve since June, will be tasked with securing ISO certification of Irvine, Calif.-based CoreValve USA and managing the clinical trial for the ReValving percutaneous aortic valve system to support European regulatory approval. He is also responsible for interacting with FDA. Previously, Thyagarajan served in senior research and regulatory management roles at cardiac implant start-ups 3F Therapeutics and VenPro. He also worked at Edwards Lifesciences before its spin-off from Baxter in 2000. CoreValve recently said it may go public in 2007 (1"The Gray Sheet" Nov. 21, 2005, p. 17)...
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