FDA grants 510(k) clearance to Venous Health's Vasculaire Compression System in the US

Feb 15 2011

Venous Health Systems, Inc., a developer of solutions for treating vascular insufficiency by enhancing blood circulation, today announced that it has received 510(k) clearance from the Food & Drug Administration to market the Vasculaire™ Compression System in the United States.

The Vasculaire Compression System is a portable pneumatic device for treating vascular insufficiency. It features an innovative platform technology comprised of a fully-portable pneumatic controller attached to a patented multi-cell 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 well within the range of values reported by the market-leading sequential pneumatic compression system. Without air lines or power cords, the Vasculaire Compression System represents a long-awaited solution for the hospital, extended care facility, and home markets.

"The Vasculaire Compression System is unique because it delivers performance in a palm-sized unit directly attached to the patient's calf sleeve," says Richard A. Lotti, President and CEO of Venous Health Systems. "Unlike other pneumatic compression devices which can weigh up to 12 lbs, the Vasculaire Compression System weighs less than 1 lb, thereby enabling patient mobility and potentially leading to increased patient compliance."

The Vasculaire Compression System is used as a prophylactic therapy to prevent Deep Vein Thrombosis (DVT), a vascular disease that may lead to a pulmonary embolism (PE). The System is also indicated for enhancing blood circulation; reducing edema; diminishing post-operative 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.

Venous Health Systems is a privately-held company founded in 2009 by Thomas J. Fogarty, MD, a legendary physician and entrepreneur in Silicon Valley. "We are excited to bring yet another innovative device to the market," says Dr. Fogarty. "We believe that a truly portable pneumatic compression device provides a vital clinical therapy for many patients."