Sky’s W3 Geko Neurostimulation Device Cleared as Therapy for Venous Insufficiency and Ischemia

March 25, 2022—Sky Medical Technology Ltd, which is based in the United Kingdom, announced that the company’s new W3 Geko device has received FDA 510(k) clearance for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia.

In December 2021, the company announced FDA clearance for the W2 Geko device, also authorized for venous insufficiency and/or ischemia.

Sky Medical’s noninvasive, wearable Geko device is the size of a wristwatch. It is worn at the knee to gently stimulate the common peroneal nerve activating the calf and foot muscle pumps. This action increases blood flow in the deep veins of the calf, at a rate equal to 60% of walking without a patient having to move. The device operates without external pressure to the leg and allows complete mobility.

According to the company, the W3 Geko features a third electrode that enables increased patient reach (nerve stimulation), patient comfort, and better patient outcomes with an increase to two 12-hour therapeutic doses. By contrast, the W2 device provided two 6-hour doses.

Recently published studies used laser speckle-contrast imaging to demonstrate that the Geko device generated microcirculatory blood flow increase in the lower limbs of patients with venous insufficiency and ischemia, noted Sky Medical Technologies.