The Food and Drug Administration (FDA) has granted 510(k) clearance to the geko™ device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia.
The neuromuscular stimulation device is applied externally to the outer/posterior aspect of the knee. The positioning enables the electrodes to apply a stimulus to the common peroneal nerve, which controls the contraction of the calf muscles. This results in increased blood flow in the deep veins of the calf.
The safety and effectiveness of the geko device was evaluated in multiple clinical trials. Using laser speckle contract imaging to measure blood flow, results showed that the device increased microcirculatory blood flow in the lower limbs of patients with venous insufficiency and ischemia.
“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,” said CEO and Founder Bernard Ross. “With this 510(k) and in partnership with leading US clinicians we can now press ahead to redefine the way vascular related conditions can be treated.”
- Sky wins FDA clearance to market the geko™ device for venous insufficiency and ischemia – a therapy area sorely in need of innovation. News release. Sky Medical Technology Ltd. Accessed December 16, 2021. https://www.prnewswire.com/news-releases/sky-wins-fda-clearance-to-market-the-geko-device-for-venous-insufficiency-and-ischemia–a-therapy-area-sorely-in-need-of-innovation-301446803.html.
- Geko™ circulation support instructions for use. Accessed December 20, 2021. https://www.gekodevices.com/us/geko-products/ifus/.