Sky Medical’s Geko Wearable Neurostimulator Cleared by FDA as Therapy for Venous Insufficiency and Ischemia

December 16, 2021—Sky Medical Technology Ltd, which is headquartered in the United Kingdom, announced it has received FDA 510(k) clearance to market the Geko electrical neuromuscular stimulator for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia.

The company stated that the Geko device is a noninvasive, easy-to-use, wearable therapy device that is the size of a wristwatch and worn at the knee. The disposable device gently stimulates the common peroneal nerve, activating the calf and foot muscle pumps and resulting in increased 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, recently published studies demonstrated that the Geko device generated microcirculatory blood flow increase in the lower limbs of patients with venous insufficiency and ischemia as measured by laser speckle contrast imaging.

The company noted it is in the process of submitting additional FDA 510(k) applications to expand its claims related to blood flow increase to address venous insufficiency.

The company’s Chief Executive Officer and Founder Bernard Ross commented in the press release, “Achieving this latest 510(k) clearance is a significant milestone for Sky that will allow us to initiate a controlled market release of the Geko device to address venous insufficiency and ischemia in the first instance—a therapy area sorely in need of innovation. With this 510(k) and in partnership with leading United States clinicians, we can now press ahead to redefine the way vascular-related conditions can be treated.”

The Geko device adds to Sky’s portfolio of previously FDA-cleared devices for edema reduction and for stimulation of the calf muscles to prevent venous thrombosis in both surgical and nonsurgical patients, noted the company’s press release.