CEO: Allegations of marketing unapproved use of medical device are false
The CEO of Maple Grove-based Vascular Solutions on Tuesday told investors that federal indictments against the company and himself of conspiring to market a medical device for unapproved uses are false.
Last month, a federal grand in Texas indicted both Vascular Solutions and CEO Howard Root on charges of promoting use of the company's products in ways not specifically approved by the federal Food and Drug Administration.
The devices are from the Vari-Lase line of lasers, needles and other accessories used to treat varicose veins. Federal prosecutors say the company and Root conspired to sell the equipment to treat twisting "perforator" veins that connect superficial and deep vein systems.
Doctors have that choice, but manufacturers are banned from marketing them that way. Speaking to investors in New York, Root denied the allegations. He said he's "not the guy who plays fast and loose with compliance."
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Root also predicted that federal officials will lose the case if it goes to trial.
"There is a culture that is a problem in the U.S. Attorney's Office," he said. "Certain people there want to put notches on their belts with criminal convictions for something that is not a crime, nothing that actually happened."
Root estimates that Vascular Solutions will spend about $2 million a year preparing for a trial that's likely a year or two away. According to the company, the vein product at the heart of the case accounted for only about $500,000 in sales over seven years.
The United States Attorney's Office for the Western District of Texas declined comment.