Vascular Responds To Grand Jury Indictment

(RTTNews) - Medical device company Vascular Solutions Inc (VASC) Thursday responded to an indictment returned today by a federal grand jury in the Western District of Texas, over charges related to the now-discontinued Short Kit version of its Vari-Lase product for the treatment of varicose veins in the leg.

As previously disclosed, the U.S. Attorney's Office in San Antonio and the Consumer Protection Branch of the Department of Justice conducted a four-year investigation concerning the since-discontinued Short Kit version of its Vari-Lase product for the treatment of varicose veins in the leg.

That investigation led to today's indictment, which alleges that members of Vascular Solutions' sales force spoke to physicians about the use of the Short Kit to treat varicose perforator veins in the leg.

The indictment further alleges that the treatment of a leg's perforator veins, as opposed to the more-commonly treated saphenous veins, is outside the Short Kit's labeled indications and therefore constitutes an 'off-label' use.

Also the indictment charges Vascular Solutions and its Chief Executive Officer with introducing adulterated and misbranded medical devices into interstate commerce and conspiracy to introduce adulterated and misbranded medical devices into interstate commerce.

In a statement, Vascular said, "The allegations against us are false and we will contest them vigorously. The indictment is the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation."

"We vehemently disagree with both allegations: we did not engage in any illegal off-label promotion of the Short Kit, nor did we engage in any false or misleading conduct," Vascular said. "The discrepancy between the insignificance of our Short Kit product and the severity of the government's actions in this matter is simply astonishing," Vascular said.

A grand jury indictment is not a verdict or finding of guilt, but rather a determination of whether a crime should be charged. Only the prosecuting attorney is allowed to present evidence to the grand jury, and no judge or defense attorney is present during the grand jury sessions. The validity of the charges included in the indictment is determined only by a jury following trial.

The Vari-Lase Short Kit was sold in the U.S. from October 2007 through July 2014 under an FDA 510(k) clearance for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

According to Vascular, 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% of its total U.S. sales during those years. Over two-thirds of the company's 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, it said.

The criminal investigation is related to a qui tam "whistle-blower" civil lawsuit filed in 2010.