Sky Medical Technology Ltd has received additional FDA authorization to market the new geko device variation for enhancing microcirculatory blood flow in lower limb soft tissue of people with venous insufficiency and ischemia, according to the company.

The company's previous FDA authorization for the device, which is also approved for venous insufficiency and ischemia, was granted in 2021. The new (W3) geko device approval adds a third electrode, allowing for greater patient reach (nerve stimulation), patient satisfaction and better results as well as an increase to two 12-hour therapeutic doses, up from two six-hour doses with the (W2) device.

Reduced blood flow in the veins and arteries causes venous insufficiency and ischemia. This can cause edema in the lower limbs, as well as skin changes and discomfort. Venous insufficiency can proceed to chronic venous insufficiency (CVI), a significant illness that causes a reduction in quality of life and productivity at work. In most cases, faulty valves are to blame. Approximately 150,000 people are diagnosed with chronic venous insufficiency each year, with roughly $500 million spent on their care. CVI can proceed to post-phlebitic syndrome and venous leg ulcers if venous insufficiency and ischemia are not addressed.