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FDA clears Venous Health Systems Vasculaire Compression System

Venous Health Systems, a developer of solutions for treating vascular insufficiency by enhancing blood circulation, has received 510(k) clearance from the Food and Drug Administration (FDA) to market the Vasculaire Compression System in the US.

The Vasculaire Compression System is a portable pneumatic device for treating vascular insufficiency and features a platform technology comprised of a fully-portable pneumatic controller attached to a patented multi-cell compression sleeve.

The Vasculaire Compression System is used as a prophylactic therapy to prevent Deep Vein Thrombosis (DVT), which leads 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 president and CEO Richard Lotti said the Vasculaire Compression System delivers performance in a palm-sized unit directly attached to the patient’s calf sleeve.

"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," Lotti said.