Federal grand jury indicts Vascular Solutions CEO
Published 10:37 am Friday, November 14, 2014
MINNEAPOLIS — A federal grand jury in Texas indicted the CEO of Minnesota-based medical device maker Vascular Solutions Inc. Thursday on charges he conspired to sell a varicose-vein treatment device for unapproved uses.
Howard Root, 53, was indicted on nine counts of conspiracy and introducing an unapproved and adulterated medical device into interstate commerce, the Star Tribune reported. The company Root co-founded, Vascular Solutions, also was indicted.
Prosecutors allege the company marketed a device to use laser heat to seal off veins deep in the leg, even though the Vari-Lase device kit only was approved for superficial blood vessels near the surface of the skin. They say the company marketed the device for use on deeper veins even after a clinical trial recorded adverse events in patients.