news

  • 17 September 2012
    Vessix receives Therapeutic Goods Administration (TGA) Approval

    Vessix Vascular, Inc., a developer of novel percutaneous radiofrequency (RF) balloon catheter technology for the treatment of hypertension, announced today that it has received approval from Australia’s Therapeutic Goods Administration (TGA) for its V2 Renal Denervation System™ for the treatment of hypertension. Renal denervation is a percutaneous, catheter-based therapy that uses RF energy to disrupt renal sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure.

    TGA approval enables Vessix to market its patented V2 System throughout Australia.

    Hypertension is the leading attributable cause of death worldwide. According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease and a 7 percent decrease in overall mortality. Renal denervation has shown in published clinical studies to be safe, durable and effective in reducing systolic blood pressure by approximately 20 percent.