FDA Clears Vasculaire Compression System to Treat Vascular Insufficiency

February 15, 2011—Venous Health Systems, Inc. (Portola Valley, CA) announced that it has received 510(k) clearance from the US Food & Drug Administration to market the Vasculaire compression system in the United States.

According to the company, the Vasculaire compression system is used as a prophylactic therapy to prevent deep vein thrombosis and the potential for it to lead to a pulmonary embolism. The system is also indicated for enhancing blood circulation; reducing edema; diminishing postoperative pain and swelling; reducing wound healing time; the treatment of stasis dermatitis, venous stasis ulcers, and arterial and diabetic leg ulcers; and the treatment of chronic venous insufficiency.

The Vasculaire compression system is a portable pneumatic device for treating vascular insufficiency. The system weighs less than 1 lb and does not have air lines or power cords. It features a fully portable, palm-sized pneumatic controller attached to a multicell compression sleeve. When the compression sleeve is placed on the patient's calf and foot and the controller is activated, the cells promote circulation with a sequential rapid inflation wave-like motion. The increase in venous velocity achieved using the Vasculaire compression system tests within the range of values reported by sequential pneumatic compression systems, the company stated.