Venous Health's Vasculaire compression system gets US clearance
This article was originally published in Clinica
The US FDA has granted 510(k) clearance for Venous Health Systems' Vasculaire compression system, a pneumatic device for treating vascular insufficiency. It comprises a portable, palm-sized controller that is attached to a compression sleeve which is placed on the patient's calf and foot. When activated, the sleeve inflates with a wave-like motion, thereby enhancing circulation, which could help prevent deep vein thrombosis. Portola Valley, California-based Venous Health says its product, weighing 0.5kg, has an advantage over more cumbersome existing devices, which can weigh up to 5.4kg, as it enables patients to move around, which could improve compliance. Unlike older devices, Vasculaire also does not need air lines or power cords, the company added.
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