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Martin Moylan
St. Paul, Minn.

Vascular Solutions CEO indicted over devices' unapproved use

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A Texas federal grand jury indicted Maple Grove-based Vascular Solutions, Inc. and its CEO Howard Root Thursday for allegedly selling medical devices with the intent they would be used for unapproved purposes.

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 the superficial and deep vein systems," according to the indictment.

The U.S. Attorney's office in San Antonio alleges the company came up with a "Short Kit" in 2007 to use on the smaller veins. When the FDA declined to approve the new Vari-Lase kit for marketing, Vascular Solutions sold the device anyway.

Vascular Solutions and Root "were aware that VSI had not received any form of FDA marketing authorization to sell Vari-Lase devices for use in treating perforator veins," the indictment said. "Nevertheless they distributed Short Kits and Vari-Lase products for this unapproved intended use from 2007 through May 2014. [Root] oversaw this conduct from beginning to end."

Root and Vascular Solutions are each charged with one count of conspiracy and eight counts of introducing adulterated and mis-branded medical devices into interstate commerce.

Doctors may choose to use something for an unapproved use. But manufacturers may not market medical devices that way.

Vascular Solutions said the allegations are false and the "profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation."

"Sales of the Short Kit for all clinical uses during the seven years it was on the U.S. market were $534,000, representing just 0.1 percent of our total U.S. sales during those years," a statement issued by the company said Thursday. "Over two-thirds of our sales representatives never sold even a single Short Kit, and the Short Kit has never been the subject of any reported serious adverse event in any patient."

A conviction could result in the company's exclusion from participation in federal health care programs.