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 Thursday on nine counts of conspiracy and introducing an unapproved and adulterated medical device into interstate commerce, the Star Tribune (http://strib.mn/1wYLGc6http://strib.mn/1wYLGc6 ) 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.
In a statement, Root, a lawyer and entrepreneur who co-founded the Maple Grove-based company in 1997, said he intends to plead not guilty. He declined to be interviewed Thursday.
"Allegations that we conducted an off-label campaign resulting in almost no sales are absurd and will not stand," Root said in his statement. "We welcome the chance to demonstrate the truth before the Court."