INSIDE RIMI expands varicose vein therapy 6 VenaSeal comes to Colorado 12 34 groups ask for shortened MU deadline 16 Getting onboard with secure texting 18 How to “market” new physicians 21
APRIL/MAY 2016 Vol. 9 No. 3 VEINTHERAPYNEWS.COM
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Jury acquits Vascular Solutions, Root of ‘off-label’ promotion of its Vari-Lase Short Kit Vascular Solutions and CEO Howard Root have been found not guilty in a federal court case claiming that the company improperly marketed a device to treat varicose veins. A jury in the Western District of Texas in San Antonio unanimously ruled not guilty on all charges against Vascular Solutions and Root over alleged “off-label” promotion of the company’s Vari-Lase Short Kit. The ruling prompted Senior U.S. District Judge Royce Lamberth to submit an order to dismiss the case that is final and not subject to appeal. But Root is still angry about the former allegations and wants the Department of Justice (DOJ) to own up to its false claims about the company. “The company and I are vindicated by today’s verdict, but outraged by the obscene legal process we were forced to endure,” Root said in a statement. “There is simply no excuse for abusive and dishonest conduct in any U.S. governmental agency, much less
What comes first. . .
HAPPINESS or SUCCESS? By Jeff Miller It’s Monday. You walk by your front desk and overhear a conversation between your office manager and receptionist who are oblivious to your presence. The lobby is empty since it’s early in the morning
and your first patient hasn’t arrived. They are talking football! And they are laughing and having a blast recounting last night’s big game. HAPPINESS
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in the Department of Justice and our law enforcement agencies.” Root specifically called out Assistant U.S. Attorneys Bud Paulissen and Christina Playton of the Western District of Texas, Consumer Protection Branch Trial Attorneys Timothy Finley and Charles Biro, and FDA Special Agent George Scavdis. In 2013, grand jurors in the San Antonio court charged Root and Vascular Solutions with conspiracy and illegal promotion of its Vari-Lase Short Kit after a former employee filed a whistleblower suit against the company. Vascular Solution’s device was approved to treat varicose veins near the surface of the skin, but Root was charged with telling sales teams to market the product for short vein segments deeper in the leg.
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Merz selects AngioDynamics to market Asclera to vein clinics AngioDynamics has signed an agreement with Merz North America to be the exclusive distributor of Asclera (polidocanol) Injection within the vein market in the United States. Merz has always been the sole marketer of Asclera. Going forward, AngioDynamics will market Asclera to the venous market while Merz continues to market it to the dermatology market. AngioDynamics has had a longstanding distribution deal with Mylan Labs to market Sotradecol, a competing drug, but that agreement ends in June. Asclera was approved by the U.S. Food and Drug Administration in 2010 for the treatment of uncomplicated spider and uncomplicated reticular (small varicose) veins. Asclera, like other pharmaceutical sclerosing agents, irritates the interior walls of the vein, causing them to constrict and close.
This prevents the flow of blood through the affected vein and can effectively eliminate the swelling, bulging, discomfort and discoloration which may be caused by small varicose veins or spider veins. In a multicenter, randomized, double-blind, placebo and comparator-controlled trial of patients with spider or reticular varicose veins, 95 percent of patients treated with Asclera showed good improvement or complete treatment success as rated by physicians; and 87 percent of patients were satisfied or very satisfied with their Asclera treatment . “At AngioDynamics, we believe that Asclera represents the future of sclerotherapy vein treatment,” said Joseph M. DeVivo, president
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April/ May 2016 - Vol.9, No.3