MINNEAPOLIS (AP) — 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 (http://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."
Vascular Solutions also issued a statement, calling the indictment "the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation."
Vascular Solutions has noted that the Vari-Lase "short kit," which was pulled off the market in July, had U.S. Food and Drug Administration approval for other varicose-vein procedures. However, the FDA says the company did not have permission to market for procedures deeper in the leg.
Prosecutors say the company's laser-powered varicose-vein kit was being marketed as a tool to seal off deeper veins than had been approved by the FDA, in violation of the Food, Drug and Cosmetic Act. Such off-label use accounted for as much as 25 percent of sales of the device. Company filings say the specific kit involved in the case amounted to $534,000 in sales between October 2007 and July 2014, when it was pulled off the market.
In addition to Root, the grand jury also indicted the corporation on the same nine counts for allegedly encouraging doctors to use the Vari-Lase Short Kit device for off-label uses.
Information from: Star Tribune, http://www.startribune.com