Spectranetics search warrant
This article was originally published in The Gray Sheet
Executive Summary
Maker of CVX-300 excimer laser systems is jointly served by FDA and U.S. Immigration and Customs Enforcement with a search warrant Sept. 4, issued by the U.S. District Court, District of Colorado. The warrant requests information and correspondence related to the promotion, testing and marketing of certain products for the treatment of in-stent restenosis and related payments made to medical personnel and one institution; the promotion, testing, delivery and marketing of catheter guidewires and balloon catheters manufactured by third-parties located outside of the U.S.; two post-market studies completed from 2002-2005 and payments tied to those studies; and compensation packages for some Spectranetics personnel. The firm says it is cooperating fully and expects business to continue as usual. The firm's stock price fell 47% on Sept. 4 to $4.73
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Spectranetics settlement
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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