Devon's lymphoedema pumps get FDA nod
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Devon Medical Products' CircuFlow 5100 and 5200 sequential pumps, for the treatment of venous insufficiency and lymphoedema. The former is caused by impaired blood flow through the veins, while the latter occurs when the lymph system is damaged or blocked, leading to a build-up of lymphatic fluid and swelling. It can be caused by cancer and cancer therapies that damage lymph vessels or require the removal of lymph nodes. The CircuFlow pumps apply gradient pressure to move lymphatic fluid and blood in the correct direction, mimicking natural circulation. Patients wear four-chambered sleeves that surround the affected area, and the CircuFlow devices pump and release air in and out of these chambers.
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