A federal grand jury in Texas has indicted the CEO of Minnesota-based medical device maker Vascular Solutions Inc. on charges he conspired to sell a varicose-vein treatment device for unapproved uses.
The Star Tribune (http://strib.mn/1wYLGc6 ) reports Howard Root was indicted Thursday on nine counts of conspiracy and introducing an unapproved and adulterated medical device into interstate commerce. The company Root co-founded, Vascular Solutions, also was indicted.
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Prosecutors allege the company marketed a device to use laser heat to seal off veins deep in the leg, even though the device only was approved for superficial blood vessels. They say the company marketed the device for use on deeper veins even after a clinical trial recorded adverse events in patients.
Root said in a statement he intends to plead not guilty.
Information from: Star Tribune, http://www.startribune.com