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Spectranetics settlement

This article was originally published in The Gray Sheet

Executive Summary

Excimer laser system maker Spectranetics will pay $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims that it illegally imported and sold unapproved medical devices from overseas manufacturers, failed to meet clinical trial reporting requirements and promoted certain products for unapproved uses, the Justice Department announced Dec. 29. In addition to the civil settlement, the firm entered into a non-prosecution agreement and corporate integrity agreement to resolve the matter. According to the non-prosecution agreement, Spectranetics accepts responsibility for its conduct and will not be criminally prosecuted. As part of the integrity agreement, the firm's clinical trial records will be audited by an independent review organization "to insure compliance with FDA rules - including reporting of adverse events," HHS Inspector General Daniel Levinson said. FDA and U.S. Immigration and Customs Enforcement had served Spectranetics with a search warrant requesting information related to the matter in September 2008 (1"The Gray Sheet" Sept. 15, 2008)
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