Devon Medical Products has received the US Food and Drug Administration (FDA) 510(k) clearance to market its CircuFlow 5100 and 5200 Sequential Pump models that treat venous insufficiency and lymphedema.
CircuFlow applies gradient pressure to mimic the lymphatic system by moving lymphatic fluid in the correct physiological direction.
Patients wear four-chambered sleeves that surround the infected area. The CircuFlow pumps and releases air into and out of the sleeves’ chambers to stimulate circulation and keep fluid from building up.
The CircuFlow’s automatic deflation device uses a vacuum to deflate the sleeves in two to five minutes after therapy is administered.
Devon said that the 5100 and 5200 models have different aesthetic and user features, including digital and mechanical controls, chamber-based gradient pressure adjustments and screen displays.
Devon Medical Products CEO John Bennett said that daily pneumatic, sequential compression using devices like the CircuFlow has proven to help treat lymphedema and venous insufficiency by stimulating the correct flow of fluid.
“The CircuFlow is the latest medical device in our product line, and we are proud to offer patients another quality device that can improve their quality of living,” Bennett said.